Fedrfp

ABOUT THE PROGRAM

The Office of Regulatory Activities (ORA) provides regulatory and clinical support across the full life cycle of FDA-regulated medical products sponsored by the Department of Defense. This position supports ORA on site at Fort Detrick, Maryland, working alongside government scientists, clinicians, and regulatory professionals under the DHA Research and Development / USAMRDC enterprise.

THE ROLE

Monitor DoD-sponsored clinical trials on site and remotely, protecting data quality and participant safety. Expect travel to clinical sites inside and outside the continental United States.

WHAT YOU WILL DO

•      Perform site qualification, initiation, interim, and close-out visits, on site and remotely.

•      Develop, implement, and maintain clinical monitoring plans.

•      Perform Source Data Verification and review source documents for completeness, accuracy, and consistency.

•      Generate and resolve data queries within SOP timelines to keep study milestones on schedule.

•      Review and maintain clinical site regulatory files and prepare site initiation training.

•      Prepare clinical monitoring reports documenting activities, findings, and follow-up.

•      Document deviations and non-compliance and support CAPA implementation.

WHAT YOU NEED

•      3-6 years of clinical monitoring experience.

•      Working knowledge of 21 CFR 312, 21 CFR 812, ICH E6, and GCP.

•      Demonstrated Source Data Verification experience.

•      Willingness to travel to CONUS and OCONUS clinical sites.

•      Strong written reporting skills.

NICE TO HAVE

•      CCRA or comparable certification.

•      Experience monitoring device or biologic trials.