Regulatory Affairs Coordinator — Research Compliance

The Henry M. Jackson Foundation for the Advancement of Military Medicine; Bethesda (MD); Sur place; USD 40 000 - 53 000; Plein temps

Avantages offerts par ce poste

Medical coverage

Dental coverage

Vision coverage

Health savings account

Retirement plans

Résumé du poste

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) seeks a Regulatory Affairs Coordinator to support compliance across human subjects, animal use, DNA, and HIPAA programs.

This entry-level role sits within the Clinical Regulatory Affairs & Compliance Office at HJF Home Office in Bethesda, MD. HJF is a nonprofit dedicated to military medicine, serving military, academia and government clients while bridging the gap between researchers and partners.

Qualifications

• Bachelor’s Degree in a science related field required.
• Minimum of 0-2 years of experience required.
• At least 1 year of relevant experience preferred.
• Knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA, HIPAA.
• Excellent communication and writing skills, interpersonal and organizational skills.
• Must be a self-starter, be able to work independently, and able to multi-task.

Responsabilités

• Assists with the review of protocols, grants, contracts, clinical trials and other research activities to ensure compliance with relevant federal and local regulations and polices of research involving human subjects, laboratory animals, select agents, utilization of recombinant DNA and HIPAA.
• Assists with maintaining a regulatory database and tracking database to include data entry, queries, and reports.
• Ensures required protocols are registered and up to date in clinicaltrials.gov.
• Reviews research personnel training for assigned portfolio to ensure that participating personnel have received appropriate training in human subjects research protection, HIPAA, animal research protection, Good Clinical Practices, conflicts of interest in research, responsible conduct in research, and shipping dangerous goods have been completed.
• Maintains effective relationship with research staff, Principal Investigators and Institutional Review Boards’ (IRBs) regulatory personnel, and others to ensure continued scientific operational functioning of protocols in assigned portfolio.
• Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
• Review and process research participant travel and reimbursement and request for clincards.
• Assists with completion of documents related to regulatory submissions for assigned portfolio and ensures they are submitted prior to their respective deadlines.
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Connaissances

Regulatory knowledge

Communication skills

Self-starter

Multitasking

Independent work

Formation

Bachelor’s degree in science-related field

Outils

MS Word

Excel

PowerPoint

Access

FileMaker

Adobe Acrobat Pro

Email

Description du poste

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) seeks a Regulatory Affairs Coordinator to support compliance across human subjects, animal use, DNA, and HIPAA programs.

This entry-level role sits within the Clinical Regulatory Affairs & Compliance Office at HJF Home Office in Bethesda, MD. HJF is a nonprofit dedicated to military medicine, serving military, academia and government clients while bridging the gap between researchers and partners.