Clinical Protocol Coordinator - NIH - Rockville, MD
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Clinical Protocol Coordinator to work onsite with the National Institutes of Health in Rockville, MD.
OVERVIEW. This is a long-term, open-ended contract position which offers:
- Competitive salary with a comprehensive benefits package.
- Tremendous room for personal growth and career development.
- Opportunity to work at the the National Institutes of Health (NIH), the world's foremost medical research center.
TASKS/SERVICES. The contractor shall:
- Assist in the day to day operation of the Division of AIDS (DAIDS) protocol registration activities including but not limited to coordinating and leading meetings, and discussions regarding all aspects of protocol registration; serve as contact for all protocol registration activities for DAIDS.
- Primary reviewer of all protocol registration deliverables including but not limited to standard PR reports, PR notification messages, review and recommend approval to Federal Client of all Investigator or Records, and Clinical Research Site regulatory documentation that include IRB/EC documentation, Forms FDA 1572/DAIDS IoR Forms, and site-specific informed consent forms to ensure all applicable regulations are met.
- Member of DAIDS working groups and committees to communicate information regarding protocol registration policies and requirements.
- Maintain and assist in the design of all protocol registration related trainings for DAIDS including but not limited to e-training modules and present proposals/materials to the PR Team Leader for approval prior to implementation.
- Evaluate and identify issues that are or may be problematic related to protocol registration and recommend policy and procedural changes to improve operations to the DAIDS PR Team Leader prior to implementation.
- Reviewer of protocol registration-related reports and documents from contractors (SOPs, quarterly and annual progress reports, timelines, procedure changes, etc.).
- Assist in the continued development of the DAIDS Protocol Registration System (DPRS) module in the DAIDS ES.
- Provide guidance, consultation and expert advice on regulations, policies and procedures to DAIDS staff and researchers and to domestic and international research organizations involved in DAIDS-sponsored research.
- Analyze and interpret regulations, policies and procedures and provide oral and written explanations and recommendations.
- Establish quality assurance standards and metrics for PR policies and procedures.
- Coordinate and communicate with other DAIDS, NIAID and NIH counterparts to ensure consistency and harmonization of regulatory procedures and strategies.
- Advise DAIDS leadership on compliance with regulations, policies and procedures related to protocol registration.
REQUIREMENTS. The contractor must have:
- Master's degree in Life Sciences or other related discipline. Three (3) years of specialized experience plus a Bachelor's degree is equivalent to a Master's degree.
- Minimum of five (5) years of experience in a related field.
- Expertise in the fundamentals of clinical trials.
- Experience in clinical data management, database operations and analysis.
- Familiarity with IRB requirements.
- Strong oral and written communication skills.
- Strong organizational skills and the ability to work independently and as part of a team.
- Knowledge of humans subjects protections regulations 45 CFR 46, 21 CFR 50 and 56, regulations pertaining to investigational new drugs and sponsor responsibilities 21 CFR 312, and Good Clinical Practice.
PLEASE APPLY ONLINE.
Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All 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 provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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