- Provide project management of day-to-day DAIDS TMF activities including but not limited to coordinating and leading meetings, and discussions regarding all aspects of trial master files.
- Serve as the primary reviewer of TMF deliverables including but not limited to standard TMF reports, TMF messages, and TMF documents in electronic systems.
- Manage and design TMF related training for DAIDS and collaborators and present proposals/materials to the federal client for approval prior to implementation.
- Coordinate and communicate to provide support and guidance to various functional areas supporting DAIDSTMFs.
- Provide support of DAIDS TMF operations during TMF implementation, audits, and/or regulatory inspections.
- Ensure TMF's are "inspection ready" at all times and TMF documents are filed contemporaneously.
- Monitor and identify trends, communicate issues, and recommend policy and procedural changes to improve operations to the federal client prior to implementation.
- Represent DAIDS on working groups and committees to communicate information regarding TMF policies, procedures, and requirements.
- Provide guidance, consultation and expert advice on regulations, policies and procedures to DAIDS staff and collaborators.
- Establish quality assurance standards and metrics for TMF policies and procedures.
- Ensure DAIDS compliance with all regulations, policies and procedures related to TMFs.
- Participate in working groups and team meetings, as required.
- Develop SOPs as required to ensure oversight of the DAIDS TMF process.
- BS degree is required, MS preferred.
- Minimum of 3-5 years of TMF specific experience is required.
- Ability to communicate effectively.
- Experience in recommending policy and procedural changes.
- Experience in managing and designing TMF-related training.
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Clinical Advisor - Bethesda, United States - CAMRIS International, LLC
Description
OverviewWe are seeking a Clinical Advisor to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent, diverse and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.
CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
Responsibilities
Qualifications
CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.
Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.
