Medical Monitor, Clinical Safety Professional

Saratoga Ascend

. Review and medically assess adverse events and serious adverse events, including causality and expectedness .

Posted 11/5/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in reviewing and medically assessing adverse events in FDA-regulated clinical research, with a strong foundation in Good Clinical Practice and regulatory compliance. Proven ability to provide consultation to multidisciplinary teams and support clinical research programs effectively.

Highest-signal resume keywords

M.D. Or D.O. With Active LicenseClinical Research ExperienceMedical Monitoring Or Drug Safety ResponsibilitiesGood Clinical Practice (ICH E6)Safety Reporting To FDA, IRBs, And DSMBs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Reviewing Adverse EventsAssessing Causality And ExpectednessReviewing Safety Data TrendsConsulting On Safety ReportingWorking Knowledge Of 21 CFR Parts 11, 50, 54, 56, 312, And 812Experience With Genetic Or Rare Disease PopulationsProtocol Deviations ReviewHuman Subjects Protections TrainingGCP TrainingClinical Monitoring

Soft Skills

Timely ConsultationCollaboration In Multidisciplinary TeamsEffective Communication

Certifications & Qualifications

Board Certification In Relevant SpecialtyCurrent GCP Training (e.g., CITI)

Industry Keywords

FDA-Regulated StudiesNIH Clinical Research ProgramsAdverse Event ReportingRegulatory ComplianceClinical Investigators

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Competitive rate
Benefit options
Equal opportunity employment protections