Regulatory Affairs Specialist - Gynecologic Cancer Center of Excellenc
- Posted: over a month ago
- Benefits: 401k, dental, life insurance, medical, vision,
Join the HJF Team!
HJF is seeking a Regulatory Affairs Specialist to support the Gynecologic Cancer Center of Excellence (GynCoe) located in Annandale, Virginia. HJF provides scientific, technical, and programmatic support services to GynCoe.
Responsible for implementing regulatory affairs, protocol, and compliance activities; ensuring accuracy, audit readiness, and compliance with awards, regulations, policies, and guidance; and supporting the Gynecologic Cancer Center of Excellence (GYN-COE) Program and the Women’s Health Integrated Research Center (WHIRC) with multi-site clinical research protocols and translational research studies aligned with military readiness, cancer capabilities, integrated women’s health, disparity investigations, precision oncology, and cancer moon shot initiatives.
NOTE: As a U.S. Government contractor, all HJF employees are required to be fully vaccinated against COVID-19 by January 18, 2022. Proof of vaccination or an approved religious or medical accommodation will be required.
- Implement regulatory, protocol, and compliance activities for the GYN-COE program and WHIRC, other research, and participating sites addressing all requirements in a timely fashion and ensuring continuous compliance with all regulations, policies, and guidance of research involving human subjects, laboratory animals, and utilization of recombinant DNA. Activities range from protocol development, execution, amendment, continuing reviews, closures to termination of all exempt determinations, minimal risk protocols, and greater than minimal risk research involving human subjects or animals. Responsibilities include managing and maintaining legacy paper and electronic regulatory binders, the delegation of authority logs, agreements, collaborators, program contacts, and critical correspondence for the GYN-COE and WHIRC portfolios. (35%)
- Implement programmatic consent reviews for protocols, honest broker activities, alignment of clinical research accounts with roles in the delegation of authority logs, staff and site monitoring assessments, and site visits to ensure compliance with regulations and human subjects protection. (20%)
- Participate in regular teleconferences and meetings to support the GYN-COE and WHIRC, advance new initiatives, best research practices, regulations, policies, and guidance. Proactively ensure audit readiness and compliance. Prepare and participate with all audits and monitoring visits. (20%)
- Actively contribute to and edit reports, briefings, abstracts, manuscripts, grants, agreements, contracts, clinical trials, and other research activities. Provide written and verbal updates. Administer abstract and manuscript submissions. Prepare and deliver PowerPoint Presentations. (15%)
- Assist with maintaining and ensuring a compliant culture and representing the GYN-COE and WHIRC in interactions with sponsors, sub-awardees, collaborators, and related personnel. Activities extend to implementing training, providing educational in-services, strengthening policies, and enhancing regulatory affairs, protocols, and compliance procedures.(10%)
- May perform other duties and responsibilities as assigned or directed by the supervisor, including participation and completion of required training and continuing education for this position.
Required Knowledge, Skills and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subjects, laboratory animals and recombinant DNA and HIPAA; knowledge of cGCPs, cGMPs, cGLPs, and ICH guideline; advanced capabilities to utilize computer systems and applications, such as MS Word, Excel, PowerPoint, Adobe DC Pro, REDcap, Nextcloud, Florence, eProtocol, eIRB, Connexus, medical record systems, and E-mail. Must have the ability to work independently, use sound judgment in solving problems, coordinate complex systems and programs simultaneously, excellent oral and written communication skills, an even temperament, and superior interpersonal and organizational skills.
Minimum Education: Bachelor’s degree required. Master’s degree preferred.
Minimum Experience/ Training Requirements: A minimum of 3-5 years of experience required.
Required Licenses, Certification or Registration: Certified as a Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) or SOCRA Certification as CCRP PRIM&R Certification as CIP, or RAPS Certification as RAC preferred.
Work Arrangement: Hybrid telework/onsite
Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC).
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
For more than 30 years, HJF has committed to a singular mission: advancing military medicine. We were authorized by Congress to do this and serve as a trusted and responsive link between the military medical community, its federal and private partners, and millions of American service families, veterans and civilians who rely every day on the advances and quality of life that result from this work.
We use our mission understanding to create innovative solutions that are purpose-built for our partners’ goals.
At HJF, you will become an important part of a mission-driven team.
The Henry M. Jackson FoundationWhy Work Here?
When you join our team, you serve one of our nearly 1,000 research programs that include infectious disease, biomedical defense, and more!
Are you ready to make a difference in military medicine? For more than 30 years, HJF has committed to a singular mission: advancing military medicine. We were authorized by Congress to do this and serve as a trusted and responsive link between the military medical community, its federal and private partners, and millions of American service families, veterans and civilians who rely every day on the advances and quality of life that result from this work. We use our mission understanding to create innovative solutions that are purpose-built for our partners’ goals. At HJF, you will become an important part of a mission-driven team.
3289 Woodburn RoadAnnandale, VA