Medical Monitor/Clinical Safety Professional

Education: M.D. or D.O. (or equivalent medical degree) with an active license required; board certification in a relevant specialty preferred.

Experience: Minimum of 5 years of clinical or clinical research experience, including prior medical monitoring or drug safety responsibilities in FDA-regulated studies.

Qualifications: Review and medical assessment of adverse events and serious adverse events, including causality and expectedness Ongoing review of safety data trends, eligibility questions and protocol deviations with the study team Consultation on safety reporting to FDA, IRBs and DSMBs Experience with genetic or rare disease populations is advantageous Availability for timely, ongoing consultation with investigators and study staff Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA Current human subjects protections and GCP training (e.g., CITI or equivalent) Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.