Senior CRA, Clinical Trial Monitor

Saratoga Ascend

. Conduct site initiation, interim monitoring and close-out visits, both on-site and remotely .

Posted 11/5/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical monitoring, including site initiation, interim monitoring, and close-out visits for NIH- or FDA-regulated trials. Proficient in source document verification, informed consent review, and compliance with Good Clinical Practice (GCP) standards.

Highest-signal resume keywords

Clinical Monitoring ExperienceSource Document VerificationGood Clinical Practice ComplianceInvestigational Product AccountabilityClinical Research Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site InitiationInterim MonitoringClose-Out VisitsAdverse Event DocumentationMonitoring Report WritingCorrective And Preventive Actions (CAPA)Protocol Compliance AssessmentGCP Compliance AssessmentInvestigational Product ReconciliationInformed Consent Review

Soft Skills

Team CollaborationCommunication SkillsProblem-Solving Skills

Certifications & Qualifications

Clinical Research Certification (CCRA, CCRP)Current Human Subjects Protections Training

Industry Keywords

NIH-Regulated TrialsFDA-Regulated TrialsGood Clinical Practice (ICH E6)21 CFR Parts 11, 50, 54, 56, 312, 81245 CFR Part 46HIPAA

About the role

Key responsibilities & impact

Conduct site initiation, interim monitoring and close-out visits, both on-site and remotely
Perform source document verification, informed consent review, and protocol and GCP compliance assessments
Review adverse event and serious adverse event documentation and reporting
Manage investigational product accountability, storage and reconciliation
Write monitoring reports, identify deficiencies, and develop and track corrective and preventive actions (CAPA)
Support NIH- or FDA-regulated clinical research programs
Work alongside Government clinical investigators, regulatory staff and program officials in a multidisciplinary team environment
Travel as required

Requirements

What you’ll need

Bachelor's degree in a life science, nursing or health-related field
Minimum of 5 years of clinical monitoring experience, with at least 3 years on NIH- or FDA-regulated trials
Hands-on experience conducting site initiation, interim monitoring and close-out visits, on-site and remote
Expertise in source document verification, informed consent review, and protocol and GCP compliance assessment
Experience reviewing adverse event and serious adverse event documentation and reporting
Experience with investigational product accountability, storage and reconciliation
Ability to write clear monitoring reports, identify deficiencies, and develop and track corrective and preventive actions (CAPA)
Willingness and ability to travel as required
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
Clinical research certification (CCRA, CCRP) preferred

Benefits

Comp & perks

Competitive rate
Benefit options