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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Trial Master Files (TMF/eTMF) and ensuring compliance with Good Clinical Practices and regulatory guidelines. Proficient in clinical trial management systems and adept at collaborating with cross-functional teams to support project deliverables.
Highest-signal resume keywords
Clinical Research ExperienceOncology Clinical Research ExperienceGood Clinical Practices KnowledgeClinical Trial Management Systems ProficiencyRegulatory Compliance
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 ManagementDocument ReviewQuality ReviewDocumentation CollectionRegulatory Issue Resolution
Soft Skills
CollaborationCommunication
Tools & Technologies
Clinical Trial Management SystemsTracking Tools
Industry Keywords
ICH GuidelinesFederal RegulationsDevelopment Innovations SOPs
About the role
Key responsibilities & impact- Set up the Trial Master File (TMF/eTMF) and collect and upload documents
- Perform initial quality reviews of documents before TMF/eTMF filing
- Partner with document specialists to maintain the TMF in audit-ready condition throughout the study
- Assist with confirming investigator and investigative-site qualifications
- Distribute and collect critical documents from investigative sites throughout the clinical trial
- Liaise with Clinical Research Associates and investigative sites to resolve outstanding regulatory issues
- Review study documents for currency, completeness, and accuracy
- Participate in cross-functional teams to support project deliverables
- Maintain clinical trial management systems and tracking tools
- Conduct documentation collection and review throughout the study lifecycle in accordance with applicable guidelines and regulations
- 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 US
- Must be able to work with clinical trial management systems and tracking tools
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