Part Time Field Specimen Technician
Details: Medical Diagnostic Laboratories, LLC (MDL) is a CLIA certified clinical laboratory with multiple state licensing, specializing in state of the art, automated DNA based molecular analysis of a variety of chronic and infectious illnesses. MDL specializes and performs Polymerase Chain Reaction (PCR) with a larger menu of testing available in the field of infectious disease. Our main theme of research is in the field of Gynecology, Infectious Diseases, Infectious Arthritis, Tick-borne Diseases, Mycology, and Chronic Fatigue Syndrome (CFS). We are currently seeking a FIELD SPECIMEN TECHNICIAN to join our growing team. This individual will be responsible for packaging specimens, completing requisitions and preparing outgoing specimens for shipment to lab via FedEx or local courier from health care facilities on behalf of Medical Diagnostic Laboratories, LLC.The schedule for this position is part time hours in the afternoon Monday - Friday. Responsibilities:-Adhere to employer's compliance policy -Prior to shipment, review accuracy of every field on test requisition forms prepared by authorized office personnel to ensure inclusion of information necessary to allow laboratory to process laboratory specimens -Complete only those fields on the test requisition, if necessary, pertaining to demographic information of patient and physician client -Maintain a high level of accuracy and confidentiality in completing requisition forms. -Obtain Missing/Invalid information from authorized office personnel upon request. -Prepare all outgoing Express/Ground specimen packages using online FedEx software applications or via communication with local courier as appropriate. -Take inventory of specimen and shipping supplies and order when necessary through Corporation Sales Support department-Perform only those tasks requested by employer not tasks on behalf of the physician's office-Perform other job related duties as required
Clinical Trial Management Associate
Details: Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have several contract opportunities for a Clinical Trial Management Associate for our client in Bridgewater, NJ. Position Brand Description: The Clinical Trial Management (CTM) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable to deliver their trial(s) with quality, on time, and within scope and budget. The CTM Associate leverages their project management, clinical trial process and scientific expertise to achieve these trial deliverables. RESPONSIBILTIES:• Use project management skills, processes and tools to develop and execute local, regional and/or global clinical trials as described below: o Timeline ? Develop and track overall trial timeline by networking, gaining alignment and integrating inputs across functions and geographies. Use the change control process to communicate changes. o Risk - Assess, identify and monitor trial-level risks. Incorporate both scientific knowledge and trial process considerations to create trial-level risk mitigation and contingency plans. o Budget - Understand the cross-functional, trial-level budget components. Create and monitor the overall budget and assumptions using financial tracking tools. Use the change control process to communicate changes. Routinely network with molecule team, including the Clinical Project Management Consultant/Associate (CPM) on trial-level budget status and changes. o Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make adjustments and changes as needed to meet the deliverables of the trial. • Facilitate local, regional and/or global, cross-functional study team meetings throughout study development and execution to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution. • Apply problem-solving skills to complex issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners). • Maintain knowledge of sourcing strategies and provide Third Party Organization (TPO) oversight, including: ¨ Understand TPO selection and qualification process. Review TPO bids and leverage Lilly?s external sourcing group to drive selection decisions. ¨ Create and manage work plan and budgets. Manage activities based on operations guides with strategic partners (functional sourcing relationships). Understand the correlation between outsourced scope of work and the trial budget to evaluate and communicate the financial status. ¨ Monitor performance metrics with TPO to ensure quality delivery, make necessary adjustments and document TPO oversight. • Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates. • Combine scientific knowledge and process expertise to impact clinical trial design, feasibility and implementation. • Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business. • Perform direct site management (DSM), if applicable, for human pharmacology and/or therapeutic exploratory clinical trials, including:o Partner with internal business partners to identify, qualify and select sites, draft investigator site budgets and initiate contract or Letter of Agreement (LoA)o Interact closely with the investigator sites to plan and implement the trialo Ensure compliance with the protocol and completion of trial deliverables according to agreed timelines o Manage site budget and investigator payments• Coordinate site initiation, monitoring and close out visits with assigned monitor/CRA. Review monitoring reports as applicable and ensure resolution/follow up of data queries and monitoring issues. Escalate unresolved quality and/or performance issues as necessary. EDUCATION/EXPERIENCE: • Bachelors or University degree (scientific or health-related field preferred)• Three years clinical research experience or relevant experience • Applied knowledge of project management methodology, processes and tools• Demonstrated ability to work cross-culturally with global colleagues and with TPOs • Demonstrated ability to manage complex situations through problem-solving , critical thinking and navigating ambiguity• Prior clinical trial site-level experience• Proficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise)• Knowledge of regulations and guidelines that apply to the conduct of clinical trials If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted. About Kelly Services®Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on
Pharmaceutical National Program Director
Details: Pharmaceutical National Program Director Publicis Clinical Solutions is currently seeking a passionate and experienced Pharmaceutical National Program Director to lead a team of Regional Field managers and Pharmacy Account Managers (PAMs). The NPD is responsible for the overall operation of the contract including achieving goals, delivering results, expense management and maximizing client satisfaction. Critical responsibilities include the timely recruitment, selection, and evaluation of the highest quality Regional Field Managers and Pharmacy Account Managers (PAMs). Trains, coaches, and develops managers in best practice methods to achieve contract goals and objectives. The NPD regularly provides direction and guidance to the Regional Management team. Develops and implements strategic plans for the client and the Company overall. The NPD is the relationship manager for the client and ensures the highest level of client satisfaction ratings. Plans, organizes and monitors activities/projects to maximize the business potential for client. The NSD is responsible for providing recommendations to client and Touchpoint Clinical Solutions’ executive team on strategies, plans and performance management. Applies strong analytical reasoning to assist client in problem solving and developing business opportunities. The NSD reports to Vice President of Touchpoint Clinical Solutions. Education/Experience:BS/BA degree required, Master’s preferred 5 or more years of management experience required Hospital experience preferred Pharmaceutical Field management/supervisory experience highly preferred Availability to travel as needed requiredPerformance Competencies:Ability to recruit, retain and develop highest quality staff Track record of positive client relationship management skills Ability to maximize contract profitability and ensure compliance Excellent people management skills; ability to develop sales representatives Excellent communication and organizational skills Ability to manage multiple priorities Expense/business management skills Computer proficient Touchpoint Clinical Solutions offers competitive compensation, a bonus plan, 401-K benefits, comprehensive benefits package, a generous car/travel allowance, and the opportunity to grow with the nation’s leader in healthcare sales. Touchpoint Clinical Solutions designs and implements customized cross-channel healthcare sales, service and clinical teams to achieve our clients’ goals. Twitter: http://twitter.com/pTouchpoint LinkedIn: http://linkd.in/pTouchpoint If you have a proven record of sales success and the desire to have a positive impact in the healthcare field, we want to hear from you. For immediate consideration, please apply online at http://www.touchpointsolutions.com/ . Touchpoint Clinical Solutions is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however; only qualified candidates will be contacted.
Lab Technician
Details: Kelly Services is currently recruiting for a Long-Term position as a Lab Technician for one of our top clients! Lab Tech is responsible for testing various analytical samples received from pulp, paper and water customers. Selected candidate will carry out rudimentary and many times repetitive techniques in support of a scientific endeavor. Activities may include glassware washing, weighing, measuring and working with chemicals. We-re looking for someone with a minimum of 3-5 years of laboratory experience with Associates degree, wet/bench Chemistry, ICP, IC/CE, Microbiological, GC, FTIR, etc and experience in Labware LIMS is desired. This is a very busy lab with a large volume of samples. If you are interested and have the above qualifications, please send us your resume.
Sr. Biostatistician - Direct Hire!
Details: Sr. Biostatistician Kelly Clinical Research has an immediate need for a Sr. Biostatistician with experience working with health outcomes and large healthcare claims databases. This is a Direct Hire position with a non-profit organization in Boston, MA. The Sr. Biostatistician is responsible for advanced statistical programming and analysis of Medicare/MassHealth co-operative projects and for contracts with the Center for Medicare and Medicaid Services. The Sr. Biostatistician analyzes data to improve health outcomes and health service delivery, designs evaluation strategies, develops proposals and executes new strategies to create new projects. Key responsibilities: Applies knowledge of statistical theory to select appropriate statistical methods. Analyzes and interprets each project’s data, using categorical data analysis and multivariate analysis techniques such as logistic regression, ANOVA, and model development. Conducts exploratory research to develop sampling methodology and calculate sample size. Uses sampling techniques to draw statistically valid samples. Answers questions regarding use of statistical techniques as posed by Staff. Writes technical notes & result summaries for all reports. Assists in developing grant proposals including writing statistical analysis sections. Conducts analysis to define, develop, validate and refine quality measures as well as creating specifications for quality measures. Project management Develops standardized approaches to programming data. Oversees and regularly reports on an auditable QA/QC program. Assures that all work products are readily available to necessary users. Communicates regularly with customers. All other duties as assigned Qualifications: Ph.D. in Biostatistics, Statistics, or Epidemiology. 5+ years of demonstrated work experience in programming, data manipulation and statistical analysis in a healthcare environment. A working knowledge of SAS, and proficiency in developing macros, use of SQL and relational databases in a client server environment. Some knowledge of MS Access, Visual Basic or other programming language preferred. Experience using SUDAAN or SPSS software preferred. Skills & Competencies: Working knowledge of SAS programming including Base SAS and macros, SAS/Graph and proc SQL preferred. Ability to program using SAS ODS to produce professional quality data reports. Extensive knowledge using Microsoft Excel. Exceptional communication and presentation skills; will represent customer at client meetings. Strong leadership and mentoring skills. Time management skills; ability to independently prioritize and handle urgent situations. Knowledge and use of project management tools and approaches Excellent analytical and problem solving skills. Ability to troubleshoot. Excellent organizational skills and capable of multi-tasking. Adaptive, able to deal with ambiguity and frequently changing requirements. Demonstrated clear, concise and understandable written and verbal communication skills. Able to write and project manage RFP responses Ability to work with internal customers in order to reach consensus of project expectations. Excellent presentation skills to diverse audiences of all sizes. Excellent listening skills. Handle information with a high level of security and confidentiality in accordance to HIPAA regulations. Focuses on meeting the needs of internal and external customers. Seeks and responds to customer feedback and maintain effective relationships with customers. Ability to collaborate all levels of staff to establish a high-functioning team that promotes the ongoing growth and support of team members. Ability to provide recommendations for continuous quality improvement of Biostatistical projects. This is an excellent opportunity for the Biostatistician that posses the qualifications and skills listed above. If this description sounds like your dream job, then please Apply Now! The customer is reviewing resumes and scheduling interviews so don’t delay. Kelly Clinical Research specializes in delivering clinical research workforce solutions to the world’s leading pharmaceutical, medical device, and biotechnology companies, as well as contract research and site management organizations. We provide contract, temp-to-hire and direct hire opportunities. Areas we specialize in include Clinical Research Associates (In-house and Field-based), Data Management, U.S. and International Regulatory Affairs, Biostatistics and Analysis, Medical Writing, Project Management, GCP Audit and Quality Assurance, Clinical Operations and Support. Kelly Services, Inc. is an Equal Opportunity EmployerAbout Kelly Services®Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on
Microbiologist
Details: MicrobiologistEvery day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an assignment available with a global medical device leader, located in Mansfield, MA. Responsibilities:Propagate and maintain appropriate microbial stocks and proper handling of pathogenic microorganisms.Prepare bacteriological/fungal media, reagents and chemical solutions including a working knowledge of media usage and validation.Perform appropriate microbiological practices and procedures for the testing of prototype formulations.Assist in conducting basic laboratory experiments applying defined protocols and procedures; generate reproducible and reliable results.Implement new microbiological techniques, test methods, and procedures.Maintain, monitor, validate and calibrate laboratory equipment as necessary.Clearly maintain and document laboratory notebooks and computer files. Maintain laboratory documentation in accordance to required scientific regulatory and intellectual property requirements.Must participate fully to achieve department safety goals/standards.Maintain a clean and safe work environment.Be self accountable to follow all safety policies & procedures after detailed training, work in accordance with safety guidelines.Requirements:Minimum B.S., in Microbiology, or related fieldMinimum of 2 years hands-on experience in a microbiology laboratory.Must have experience with Microbiology procedures and aseptic techniques.Must have the ability to execute experiments with minimal supervision.Proficient in use of standard desktop computer software programs, including: Microsoft Office, Excel, and Powerpoint.Possess the ability to collect and analyze data, including statistical analysis, and draw conclusions.Must have the ability to handle complex tasks simultaneously and possess excellent time management skills to adhere to time dependent completion dates. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must apply online to submit your resumes. If you have questions about the position, you may contact the recruiter at ; Must be authorized to work in the United States. In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect: Competitive payPaid holidays, PTOYear-end bonus programPortable 401(k) plansRecognition and incentive programsAccess to continuing education via the Kelly Learning Center Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com Kelly Services is an Equal Opportunity Employer About Kelly Services®Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on
Sciences - Quality Assurance
Details: Job Classification: Contract This position is responsible for the tactical project plan (Gant) management for designated corporate projects.Responsible for working with project managers, functional area managers and management to facilitate routine project plan updates and project data compilation. Assist PM management in maintaining reporting standards and key performance parameters and providing reports to communicate key information with departments and management. Primary contacts are project managers, department managers and finance.-Work with project managers to update project plans on routine basis and highlight and track changes.-Assist PM management to prepare reports through gathering, analyzing and summarizing data and information from the composite of all project plans.-Work with PM management to facilitate standardization of project plans and reports.-Assist with generating project summary reports for finance and general use.-Assist in generating meeting notes associated with project plan updates.-Administrative tasks and other duties as assigned. Join Aerotek Scientific®LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
Associate Director
Details: A Pharmaceutical company located in RTP, NC is seeking an Associate Director of Clinical Development to join their team. This is a full-time, in-house, permanent position. Our client offers competitive compensation benefits and other great perks. PURPOSE OF POSITION: The Associate Director of Clinical Development is responsible for providing clinical development and outside R&D for the successful management of clinical programs. They will be responsible for program planning, interpretation of data, analysis plans and study design. Our client is looking for someone with clinical expertise to Business Development teams in order to drive new product acquisitions/licenses. The right candidate will be expected to interpret clinical and scientific data from studies to support drug development programs. Presentation skills are imperative as well as the candidates’ skills to prepare abstracts and manuscripts. The candidate will have excellent knowledge of PhRMA code and current industry standards of conduct. The candidate should have a thorough understanding of all phases of drug development and regulatory requirements. Our client is looking for someone who will lead the strategic implementation of clinical development programs.EDUCATION/SKILLS: PharmD with fellowship or residency is highly preferable. The candidate should posses a PhD in a biological science or related field, MDs with appropriate experience will also be considered. Our client is looking for a candidate with a minimum of 4 years post completion of doctorate program. Clinical development experience in the pharmaceutical industry is preferred. The candidate should have previous NDA or sNDA experience as well as thorough understanding of drug development is highly preferred. Clinical research experience is required with preference in GI therapeutic area.
Sr. Maintenance Technician
Details: Maintenance Technician Our client is looking for an experienced individual who can perform routine preventative maintenance on GMP pharmaceutical processing equipment. Duties & Responsibilities- Perform timely repairs on filling equipment, chromatography skids, bioreactors, columns, transfer panels, CIP skids, etc. - Implements preventative and corrective actions towards equipment repairs. - Properly documents repair related information onto departmental logbooks or downtime sheets.Requirements- 5+ years of experience working with GMP pharmaceutical process equipment.- Strong cGMP experience is a must.- Prior certification, training and/or experience in a regulated environment (airline, food processing, etc.) is highly preferred.
Malaria Biologist
Details: Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at WRAIR. If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team. We are currently seeking a Malaria Biologist for the Silver Spring, Maryland area. RESPONSIBILITIES: Maintain and monitor in vivo rodent malaria infections upon schedule and maintain laboratory records of microscopic examinations. Prepare anopheline mosquitoes for infectious feeds on malaria-infected animals upon schedule for the production of rodent malaria infected mosquitoes. Monitor parasite development in the infected mosquitoes by dissection and microscopic examination upon schedule and maintain laboratory records of microscopic examinations. Isolate and characterize malaria parasites from infected mosquitoes. Coordinate with collaborative researchers in the institute through supervisor(s) on the provision of rodent malaria infected mosquitoes upon schedule for their research studies. Maintain records of mosquito malaria infections received from collaborators. Work independently or collectively with other lab members on rodents required to maintain the mosquito colonies and rodent malaria infections; injection of anesthetic agents and parasites; execution of mosquito feeds; euthanasia of the animals and disposal of carcasses. Evaluates infectivity and growth of genetically modified/attenuated parasites for use in various research studies and maintain transformed parasites in vivo as needed. Participate or assist in human malaria culture maintenance and mosquito rearing and colony maintenance when assigned. Conduct research studies on broad spectrum of human and rodent malaria to include but not limited to the parasite biology, their development and transmission, transmission blocking strategies, immunology of malaria and other infectious diseases, etc. Under the supervision of and upon coordination with the Department Chief, write and submit research proposals on behalf of the department to obtain intramural or extramural research funding and grants. Collect and organize laboratory data and provide basic data analysis. Provide all job-related progress reports/technical reports as requested. Regularly monitor the environmental conditions of the rodent malaria operation and mosquito holding chambers i. e. temperature and humidity according to the SOPs; report any irregular conditions immediately to the department chief, Insectary officer in charge, or lab manager; follow up and report on progress of repair. Performs light duties and other related duties as required and assigned. Participate in general laboratory housekeeping to include cleaning of glassware, disposing and transporting of biohazard materials and sharps. Maintain orderly conditions and cleanliness of the facility and ensure equipment is clean and overall operations are neat and in order. Maintain supplies in the laboratory by coordinating with the lab manager for purchase requests and stocking. Provide technical assistance to CRM Headquarters as needed and participate on proposal writing projects when requested. MINIMUM QUALIFICATIONS: Doctorate degree in a scientific discipline such as biology, entomology, microbiology, parasitology, immunology, bacteriology, virology, zoology, biochemistry, biological technology, molecular biology, or other biological science-related discipline. Experiences to include planning and conducting research studies, analyzing and interpreting research data, and fundamental laboratory techniques e. g. microscopic examination of specimens, preparation of reagents, and sterilization/disinfection techniques. Experiences with malaria parasites or insect colonization are highly desirable. Experiences in writing and submitting research grant proposals to secure funds are highly desirable. Required to work with animals (mostly rodents) and insects (mostly mosquitoes). Required Knowledge, Skills and Abilities: knowledge of applicable highly complex scientific procedures and techniques relating to position. Physical Capabilities: work may involve long periods of standing; must be able to wear personal protective equipment as required for handling of chemicals and/or biological materials; good manual dexterity and eye-hand coordination is required for mosquito dissections; agility and moderate strength is required for mosquito rearing and colony maintenance operations (reaching, stretching, cleaning, lifting buckets of water, moving equipment, etc); color vision is required (not color blind). Work environment: when assigned, required to work intermittently under laboratory environment at high temperature of up to 28°C and relative humidity of up to 80%; may require working evenings or weekends. Must be able to work independently following a brief period of specific technical training. Acquire and maintain the qualifications for animal use by attending classes and certifying for the institutional Animal Care and Use Program (ACUP) and Rodent Handling Workshop; follow the established SOPs and Animal Use Protocol for handling rodents required by the Institutional Animal Care and Use Committee (IACUC); ensure that the requirements of the animal welfare act (AWA), Department of Defense regulations or animal welfare guidelines are followed while conducting rodent malaria, Plasmodium berghei, production, other zoonosis diseases, and mosquito colony maintenance. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks. ClinicalRM is an Affirmative Action-Equal Opportunity Employer www.clinicalrm.com “NorthCoast 99” Best Places to Work recipient
Malaria Culture Lab Technician
Details: Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at WRAIR. If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team. We are currently seeking a Malaria Culture Lab Technician for the Silver Spring, Maryland area. RESPONSIBILITIES: Cultivate and maintain human malaria parasites in tissue culture and maintain laboratory records of parasite growth and differentiation. Prepare anopheline mosquitoes for infectious feeds and infect the mosquitoes with cultured malaria parasites using a membrane feeding device. Monitor parasite development in the infected mosquitoes by dissection and microscopic examination upon schedule and maintain laboratory records of microscopic examinations. Isolate and characterize malaria parasites from infected mosquitoes. Coordinate with collaborative researchers in the institute through supervisor(s) on the provision of rodent malaria infected mosquitoes upon schedule for their research studies. Maintain records of mosquito malaria infections received from collaborators. Assist in immunization of human volunteers by infected mosquito bite and execution of the challenges to vaccine study volunteers. Assist in maintenance of rodent malaria life cycle in mice and mosquitoes when assigned. Assist in maintenance of mosquito colonies when assigned. Participate in research programs when assigned. Collect and organize laboratory data and provide basic data analysis. Provide all job-related progress reports/technical reports as requested. Provide technical assistance to CRM Headquarters as needed and participate on proposal writing projects when requested. Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer. MINIMUM QUALIFICATIONS: Bachelor degree in a scientific discipline such as biology, entomology, microbiology, parasitology, bacteriology, biochemistry, immunology, virology, zoology, biological technology, or other biological science-related discipline. Experience in mammalian tissue culture techniques and malaria parasite culture techniques, is preferable. Experience in the laboratory techniques including microscopic examination of specimens, preparation of laboratory reagents, sterile techniques, and basic tissue culture techniques, is preferable. Technician will be working on human malaria parasites in BSL-2 containment. Required to work with insects. Experience with malaria parasites or insect colonization is preferable. Work in large walk-in environmental chambers where elevated temperature and humidity is necessary to maintain infected mosquitoes or colonies. Required to work evening, weekend and holiday hours. Required Knowledge, Skills and Abilities: knowledge of applicable highly complex scientific procedures and techniques relating to position. Physical Capabilities: work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. Work Environment: laboratory environment; may require working evenings and weekends. Must be able to work independently following a brief period of specific technical training. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks. ClinicalRM is an Affirmative Action-Equal Opportunity Employer www.clinicalrm.com “NorthCoast 99” Best Places to Work recipient
Clinical Nurse Educator / National Field Manager
Details: Pharmaceutical National Clinical Nurse Educator Field ManagerAre you ready for a new challenge and rewarding career opportunity?Do you enjoy developing and leading field based healthcare teams? As pharmaceutical companies continue to seek new and effective ways of providing value added services to healthcare providers and their patients, Clinical Nurse Educators help fill this need. The physicians, nurses, pharmaceutical companies, and patients all gain from the benefits/ services Clinical Nurse Educators provide. Clinical Educator teams work closely with healthcare professionals and patients to improve disease outcomes—from educating professionals on new treatment protocols to working with patients and caregivers to educate, train, counsel and support. We play an important role supplying and managing Clinical Nurse Educator teams. We are currently seeking a National CNE Field Manager, who will oversee our current team of contract Clinical Nurse Educators. This established field based team works with our client, a top Fortune 100 pharmaceutical organization. In addition to leading a nationally deployed team, CNE manager will also work with various levels of management to manage the day responsibilities of our established CNE program. Other responsibilities include continuing to build and cultivate our pharmaceutical client partnership and enhance CNE program’s success. This position is based from CNE Managers home office which should be based close to a major US airport. There will be ongoing weekly travel comprised of corporate client home office visits, on and off site training, clinical nurse education staff development and weekly field visits with clinical nurse educators. CNE’s are based throughout the US. As a Publicis Touchpoint Clinical Solutions employee you will receive a competitive base salary, generous monthly auto allowance and mileage and full approved business expense reimbursement Additional bonus opportunities available based upon performance. Excellent benefit package including 401k and ongoing career development in this highly visible and key field based position. This is an exciting opportunity to work with a highly specialized clinical nurse educator team. If you are a strong, yet compassionate leader, have successful experience utilizing your clinical nursing background in a pharmaceutical/device environment we would enjoy learning more about you. REQUIREMENTS: Minimum 5+ years experience in the pharmaceutical, device or healthcare industry. Bachelor degree required BSN or masters degree preferred. Pharmaceutical, CNE or medical device outside Clinical Educator management experience highly desired. Clinical Educator management experience a plus. Management of CNE managers desirable RN with current license in good standing preferred. Valid driver’s license with clean driving record. May live anywhere with access to a major US airport. Strong leadership, coaching and mentoring skills needed Ability to travel nationwide, up to 65% with occasional weekend travel may be required. Excellent time management skills with the ability to manage multiple priorities. Performance management experience including hiring, training, developing, evaluating. High level of internal and external focused customer service. Publicis Touchpoint Clinical Solutions offers competitive compensation, a bonus plan, comprehensive benefits package, 401-K benefits, car/travel allowance, and the opportunity to grow with the nation’s leader in healthcare marketing. If you have a desire to contribute to the healthcare field in a whole new way, we want to hear from you. For immediate consideration, please forward your resume to and apply online at http://www.touchpointsolutions.com/ Publicis Touchpoint Clinical Solutions is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however; only qualified candidates will be considered. keyword: “team leader”, “regional manager” “sales manager”, “management”, “director”, “supervisor”, " home health, nurse, "rn" "clinical liaison", "clinical specialist" "nurse educator", "bsn" "nurse practitioner" “clinical educator” “field manager” “national manager” “field director” “pediatrics”,
HVAC Specialist
Details: HVAC / Refrigeration Specialist Our client, a leading pharmaceutical company here in the bay area, is looking to hire on an in-house HVAC specialist to provide daily support to their GMP facility.Job duties:- Troubleshoot HVAC equipment and controls- Maintain HVAC equipment on an ongoing basis- Repair kitchen equipment such as walk-in coolers, freezers, refrigerators, and ice makers - Adhere to established HVAC work order preventive maintenance scheduleRequirements:- The candidate will be EPA certified and have extensive experience supporting Chillers Maintenance, rooftop compressors, rooftop units, validated systems, DP Alarms, high-end Fisher Scientific freezer units and cooling tower operations.- Previous work in a GMP / FDA regulated environment.- 7+ years of hands on experience with HVAC maintenance. This is a very senior level role.
In-House CRA Opportunity
Details: A Pharmaceutical company located in RTP, NC is seeking an In-House CRA for a 1-year contract position. This is an office based opportunity with up to 40% travel.PURPOSE OF POSITION: The In-House CRA is responsible for the tracking of all study visits and reports and make sure they are consistent with the monitoring plan. They will write trip reports and follow-up letters as required by SOPs for study visits. This person will conduct all types of monitoring, co-monitoring at study sites as required including Phase I unit pre-study evaluations and Phase I first dose visits. Some other responsibilities include being able to establish and maintain relationships with external vendors, study sites and team members to ensure professional, timely, and ongoing communication and documentation for assigned project. They will also have to be proficient in being able to track, review and prepare study-specific information utilizing databases, spreadsheets, and other tools and systems (IVRS, EDC, etc.) for reporting status updates to the team. They need to be able to prepare and negotiate Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), per subject clinical grant schedules and financial disclosure documents with internal and external parties, within parameters agreed upon with manager, as needed. This person must also be able to assist in the development and review of study specific tools, templates and documents such as monitoring guidelines, monitoring plans, CRA evaluation plans, Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plans, source document templates, monitoring visit report templates, site tools and worksheets and study reference manual.EDUCATION/SKILLS: Minimum of BS/BA and 5 years of industry experience is required. Excellent verbal and written communication skills are required.
Packaging Engineer
Details: JOB DESCRIPTION: This position requires a candidate to have hands-on experience with various package materials, package systems and package testing. The candidate is required to be proficient in Microsoft Word, Excel, PowerPoint and Outlook. Experience with MS Project and computer aided design software (i.e. AutoCAD, ArtiosCAD, SolidWorks) are considered assets. Additional training and/or certification in Process Excellence (Green Belt, Black Belt) and/or Project Management (PMP) are a plus. The individual must have excellent oral and written communication skills and the ability to negotiate and interface with team members and external suppliers. The successful candidate will be a self-starter, detail-oriented and be able to multi-task. The position is located in Somerville, NJ and does not require any travel. ADDITIONAL DETAILS: Write test protocols; perform package testing to prescribed methods; document results; analyze and interpret data and report results. Make prototypes and take photographs. Proficiently run and maintain packaging lab equipment. Maintain lab safety standards. Maintain lab organization.
Permanent CRA Opportunity
Details: A Pharmaceutical company located in Morrisville, NC is seeking a CRA or Sr. CRA. This person needs to be able to sit in-house when not traveling. This position is permanent and comes with a very competitive benefits package!PURPOSE OF POSITION: The CRA/ Sr. CRA is responsible for the tracking of all study visits and reports and make sure they are consistent with the monitoring plan. They will write trip reports and follow-up letters as required by SOPs for study visits. This person will conduct site qualification, initiation, interim monitoring, co-monitoring, and study closeout visits. Some other responsibilities include ensuring regulatory and protocol compliance of investigators and sites. They will also ensure quality of data submitted from study sites and assure timely submission of data, including proactive cooperation with data management to identify and resolve data discrepancies. This person will be expected to assist in the training and supervision of field monitors, and Contract Research Organizations. Also, being able to establish effective relationships with clinical investigators and staff, CROs, and vendors and influence them to meet study objectives is necessary. Some other responsibilities include assisting with the design and development of clinical trial protocols, case report forms, informed consent forms, and study documentation. The person should also have the ability to travel approximately 60% of the time (primarily domestic sites with potential for international travel).EDUCATION/SKILLS: The right candidate should possess an Associate degree, plus 3 years’ experience in clinical trials with 2 of those years in a monitoring role (for CRA). For the Sr. CRA an Associate degree (BS/BA desired) plus 5 years’ experience in clinical trials with 3 of those years in a monitoring role. They should have the ability to travel up to 60% including international travel. They are required to have strong site management and monitoring skills, good knowledge of the clinical development process, good understanding concepts of Phase I-IV, be able to compete projects within the deadlines set under limited direction while generating quality deliverables. Oncology experience is highly desired.
Regulatory Medical Writer (Remote)
Details: Job Responsibilities (other duties may be assigned):Responsible for communicating with Provide general administrative meeting supportKelly Clinical Research has an immediate long term contract position for a Regulatory Medical Writer with strong Phase I experience. This position requires demonstrated knowledge of completing large volume CSR's and protocols, previous experience working for a CRO is highly desired. This position is home-based but does require all work to be done within an 8 hour, Monday - Friday workday. In general the Medical Writer researches, prepares, and coordinates scientific publications; writes and edits clinical/statistical reports and study protocols; and summarizes data from clinical studies for submission to the Food and Drug Administration (FDA). Job Responsibilities (other duties may be assigned):• Interacts with sponsor to determine format, design, and direction of complex Medical Writing deliverables; designs tables and figures for presentation of data. Reviews information with the Project Manager and Biostatistician to define patient populations for analysis. Interprets statistical data to develop text. Prepares deliverables. Identifies and coordinates meetings with in house reviews to define needed revisions. • Represents Medical Writing on project teams and updates Medical Writing management on the status of projects. Acts as project manager for specific projects, including budgeting, allocation of resources, timelines, billing approval, contract negotiation, and sponsor contact. May direct the activity of a team of writers. Budgets and forecasts project-related costs and sets timelines for completion of projects. Tracks budget and timelines for projects. Prepared time and cost estimates for future projects and interacts with Bids and Contracts to prepare proposals for writing projects. May design templates for deliverables. Acts as a liaison on interdepartmental projects.• Advises Medical Writing management on the development of new processes, WPD and SOP. Researches current literature to design clinical studies. Writes complex study protocols with reference to current research and FDA guidelines. • Provides training. Acts as a mentor for Medical Writers. Participates in internal and external training as appropriate regarding guidelines and requirements of the FDA and other regulatory agencies. • Prepares materials and gives marketing presentations to potential clients on the capabilities of the Medical Writing Group. Requirements:Education and experience required:Bachelor's degree or equivalent professional experience.• Minimum of a BS/BA in a scientific discipline or licensed certification as RN or other healthcare discipline • 5+ years relevant writing experience; within the CRO industry• Ability to manage large writing projects with minimal supervision• High degree of independence in decision making and problem solving• Ability to serve as a departmental resource for training, mentoring, and the development of process improvements for Medical Writing• All requisite skills of the Medical Writer position, including excellent grammatical, editorial, and proofreading skills, and the ability to interpret and present extremely complex data- Extensive Phase I medical writing- Experience with large volume CSRs- Oncology experience- Must have tenure with employers- Prefer CRO experienceAbout Kelly Services®Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on
