CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, bio-defense, and clinical research.
CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today!
We are seeking a Medical Officer to support the overall functions of the Division of Clinical Research, Office of the Director at the National Institutes of Health (NIH).
- Evaluate existing protocols and provide suggestions for design, execution and improvement.
- Provide guidance to staff on various clinical processes and operational issues.
- Review safety reports and provides assessment of clinical implications of findings.
- Develop policies and guidelines.
- Coordinate and participate in various meetings, training and safety-related educational programs.
Medical Review Activities include:
- Study documents: participate in drafting protocols and ICFs, draft shell tables, training materials, monitoring reports for clinical aspects and adherence to protocol.
- Clinical data: tables, listings, figures, narratives, draft reports, summaries of efficacy, safety, benefit risk, regulatory responses, publications, press releases.
- Compliance: review responses to audit findings, protocol deviations and violations; draft and review SOPs.
- Draft and review position papers: on disease under study, competitive intelligence on ongoing studies and therapies, literature searches.
Team Activities (lead or participate, as needed) include:
- Protocol meetings
- Organizational and team building activities
- Training on clinical and safety components of protocol
- Presentations on strategy, protocol, data, and progress to team(s), management, study sites.
- Define/clarify roles and responsibilities, review enrollment strategies, country and site selection, speed of activation, site training, assessment of non-enrolling sites, scrutiny of high enrolling sites.
Involvement in Strategy and Organization include:
- Regulatory: strategy, submissions, writing, document review, responses
- Communications: assist in creation/management of clinical website, media materials, press releases, communications to study staff
- Clinical liaison for studies with other divisions and programs
- General: coordination and chairing of workshops, expert meetings
- Develop future strategic plans and educational materials for staff.
- Medical degree from an accredited university.
- Minimum 8 years of experience in medicine or related field.
- All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D.
- The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categories specified in the contract.