Medical Monitor, Clinical Safety Professional

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 13%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Saratoga Ascend

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1985

🏥 Healthcare

🎯 Recruiter

🏛️ Government

Healthcare • Recruitment • Government

Saratoga Ascend is a federal- and state-focused healthcare workforce and solutions firm that connects cleared, credentialed healthcare professionals with government, military, and civilian healthcare facilities across the U. S. The company provides clinical and non-clinical staffing, clinical lab and scientific staffing, call center services, federal healthcare consulting, IT solutions, program and administrative support, and SLED (state, local, education) services. With a stated four-decade legacy, nationwide coverage, rapid-fill capabilities, strict credentialing/compliance processes, and operation under federal contract vehicles, Saratoga Ascend positions itself as a government-focused healthcare staffing and program management partner.

📋 Description

• Review and medically assess adverse events and serious adverse events, including causality and expectedness • Conduct ongoing review of safety data trends, eligibility questions, and protocol deviations with the study team • Consult on safety reporting to FDA, IRBs, and DSMBs • Provide timely, ongoing consultation to investigators and study staff • Support NIH or FDA-regulated clinical research programs • Work alongside Government clinical investigators, regulatory staff, and program officials in a multidisciplinary team environment

🎯 Requirements

• M.D. or D.O. (or equivalent medical degree) with an active license required • Board certification in a relevant specialty preferred • Minimum of 5 years of clinical or clinical research experience • Prior medical monitoring or drug safety responsibilities in FDA-regulated studies • Experience reviewing and medically assessing adverse events and serious adverse events, including causality and expectedness • Experience reviewing safety data trends, eligibility questions, and protocol deviations • Experience consulting 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

🏖️ Benefits

• Competitive rate • Benefit options • Equal opportunity employment protections

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