Research Regulatory Affairs Coordinator

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.; Bethesda (MD); Sur place; USD 40 000 - 52 000; Plein temps

Résumé du poste

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

is seeking a Regulatory Affairs Coordinator to support compliance across human subjects research, animal use, recombinant DNA, and HIPAA. Based at the HJF Home Office in Bethesda, MD, the role assists in protocol reviews, database maintenance, and regulatory submissions while collaborating with IRBs and investigators to ensure timely and accurate documentation.

Qualifications

• Bachelor's Degree in a science-related field is required.
• 0-2 years of experience minimum; at least 1 year preferred.
• Knowledge of federal and local regulations related to human subjects, HIPAA, and animal research.
• Strong written and verbal communication and organizational abilities.

Responsabilités

• Assist with review of protocols, grants, contracts, and trials to ensure regulatory compliance.
• Maintain regulatory and tracking databases with data entry, queries, and reports.
• Ensure clinicaltrials.gov registration for protocols.
• Review training for personnel ensuring required protections and shipping compliance.
• Collaborate with IRBs and staff to maintain operational functioning of protocols.
• Monitor regulatory updates from federal agencies.
• Assist with regulatory submissions documents and deadlines.

Connaissances

Regulatory knowledge

Communication skills

Self-motivation

Multitasking

Organizational skills

Formation

Bachelor's Degree in a science related field

Outils

MS Word

Excel

PowerPoint

Access

FileMaker

Adobe Acrobat Pro

E-mail

Description du poste

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.

is seeking a Regulatory Affairs Coordinator to support compliance across human subjects research, animal use, recombinant DNA, and HIPAA. Based at the HJF Home Office in Bethesda, MD, the role assists in protocol reviews, database maintenance, and regulatory submissions while collaborating with IRBs and investigators to ensure timely and accurate documentation.