Clinical Project Associate
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Job Description
Clinical Project Associate maintaining audit-ready Trial Master Files for SCRI, an oncology clinical research organization. Supporting site documentation, regulatory issue resolution, and clinical trial deliverables.
Responsibilities:
- 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:
- 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:
- 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
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