The Office of Clinical Research (OCR) is responsible for monitoring and evaluating NIA’s extramural clinical research portfolio. The overarching goal is to engage broader segments of the public, including underrepresented populations, to participate in Alzheimer’s and related dementias clinical research. OCR is currently recruiting for the following positions:
Regulatory and Safety Officer
Note: This position has been filled.
OCR is seeking an exceptional candidate with experience with regulatory and safety oversight of clinical research to join OCR as a Regulatory and Safety Officer (GS 13/14). OCR coordinates contracts that support NIA’s clinical research operations and supports NIA-funded grantees in clinical research activities.
Responsibilities
The responsibilities of this position include:
- Establishment and oversight of Independent Data Monitoring Committees such as DSMB’s etc.
- Regular collaboration across NIA’s extramural divisions, external contractors, and NIA grantees regarding safety and DSMB.
- Project management, development of policies and procedures and manage multiple projects at a time as well as interacting with internal and external (clinical sites and principal investigators) collaborators.
- Contribute to the strategic planning and to the development of the internal best practices and policies.
- Obtain a Level II Contract Officer Representative (COR) certification and will serve as a backup COR for Clinical Research Support Services contract
Who should apply?
The ideal candidate should possess:
- Experience with regulatory and safety oversight of clinical research within the National Institutes of Health (NIH).
- A background in NIA mission areas of research, diseases and conditions associated with growing older, including Alzheimer’s disease and related dimensions, beneficial but not necessary
- In depth understanding of OHRP and FDA requirements including record retention, and broad experience with safety oversight of clinical research.
How to apply?
This position has been filled.
Regulatory Policy Analyst
OCR is seeking an exceptional candidate with experience with regulatory and safety oversight of clinical research to join OCR as a Regulatory Policy Analyst (GS 13/14). OCR coordinates contracts that support NIA’s clinical research operations and supports NIA-funded grantees in clinical research activities
Responsibilities
The responsibilities of this position include:
- Project management
- Developing SOPs based on best practices
- Ability to work with internal and external collaborators
- Managing multiple projects at a time
- Serve as a COR for NIA’s Clinical Research Support Services contract
- Involvement in regular collaboration across NIA’s extramural divisions
- Level II COR certification up to a Level III COR certification.
Who should apply?
- At least a level II COR Certification
- Clinical research experience and certifications are encouraged
- A background in NIA mission area of aging, research, including Alzheimer’s disease and related dementias, beneficial but not necessary
- A broad understanding of Regulatory and Policy requirements with emphasis on NIH, OHRP, and FDA requirements
How to apply?
Interested candidates should send a CV and letter of interest to Dr. Jui Shah, Chief, Regulatory Support Branch, OCR at niajobs@mail.nih.gov.