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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in maintaining Trial Master Files (TMF) and clinical trial management systems, ensuring compliance with Good Clinical Practices and regulatory standards. Proficient in document collection, review, and quality assurance throughout the clinical trial lifecycle.
Highest-signal resume keywords
Clinical Research ExperienceTrial Master File ManagementGood Clinical Practices KnowledgeClinical Trial Management SystemsOncology Clinical Research Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Trial Master File DocumentationETMF Documentation CollectionQuality Review of TMF DocumentsRegulatory Issue ResolutionDocument Distribution and Collection
Soft Skills
CollaborationCommunication
Tools & Technologies
Clinical Trial Management SystemsTracking Tools
Industry Keywords
ICH GuidelinesFederal RegulationsDevelopment Innovations SOPs
About the role
Key responsibilities & impact- Ensure the Trial Master File (TMF) is set up and maintained in audit-ready condition
- Collect, upload, and perform initial quality review of TMF/eTMF documents
- Partner with document specialists to maintain the TMF from study start to completion
- Assist with confirming investigator and investigative site qualifications throughout clinical trials
- Distribute and collect critical documents from investigative sites throughout the clinical trial lifecycle
- Liaise with Clinical Research Associates and investigative sites to resolve outstanding regulatory issues
- Review study documents to ensure they are current, complete, and accurate
- Maintain clinical trial management systems and tracking tools
- Participate in cross-functional teams to ensure delivery of project deliverables
- Perform other duties as assigned
Requirements
What you’ll need- Minimum High School Diploma or GED
- At least 1 year of clinical research experience required
- Oncology clinical research experience preferred
- At least 3 years of clinical research experience preferred
- Knowledge of Good Clinical Practices, ICH Guidelines, Federal Regulations, and Development Innovations SOPs
- Must be based in the United States
- Must be able to maintain clinical trial management systems and tracking tools
- Must be able to conduct Trial Master File/eTMF documentation collection, review, and filing
- Must be able to confirm investigator and investigative site qualifications
Benefits
Comp & perks- Comprehensive benefits supporting physical, mental, and financial well-being
- Annual bonus or long-term incentive opportunities may be offered
- Relocation assistance is not available
- Visa sponsorship is not available