This is a fully remote position, open to applicants in United States.

📋 Description

• Evaluate and medically review adverse events and serious adverse events, focusing on causality and expectedness.

• Perform continuous analysis of safety data trends, eligibility inquiries, and protocol deviations in collaboration with the study team.

• Provide guidance on safety reporting to the FDA, IRBs, and DSMBs.

• Offer prompt and ongoing consultation to investigators and study personnel.

• Assist in NIH or FDA-regulated clinical research initiatives.

• Collaborate with Government clinical investigators, regulatory personnel, and program officials in a multidisciplinary team setting.

⛳️ Requirements

• An M.D. or D.O. (or equivalent medical degree) with a valid active license is mandatory.

• Board certification in a pertinent specialty is preferred.

• At least 5 years of clinical or clinical research experience is required.

• Previous experience in medical monitoring or drug safety roles within FDA-regulated studies is essential.

• Proven experience in reviewing and medically assessing adverse events and serious adverse events, including causality and expectedness.

• Familiarity with analyzing safety data trends, eligibility questions, and protocol deviations.

• Experience in consulting on safety reporting to the FDA, IRBs, and DSMBs.

• Knowledge of genetic or rare disease populations is a plus.

• Availability for timely and ongoing consultation with investigators and study personnel.

• A minimum of five years of direct experience supporting NIH or FDA-regulated clinical research programs.

• Proficient understanding of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312, and 812 (where applicable), 45 CFR Part 46, and HIPAA.

• Current training in human subjects protections and GCP (e.g., CITI or equivalent).

• Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory personnel, and program officials.