Remote TMF QA Associate, Clinical Trials

Sarah Cannon Research Institute; Tennessee; Remote; USD 65,000 - 90,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is seeking a Clinical Project Associate to ensure TMF setup and audit-ready maintenance throughout studies, in line with GCP, ICH, FDA regulations, and SCRI SOPs. You will support TMF/eTMF processes and track deliverables with cross-functional teams.

Remote-based in the United States, the role requires basic clinical research experience; oncology trials are preferred. Relocation or visa sponsorship are not available.

Qualifications

• At least 1 year of clinical research experience required; at least 3 years of clinical research experience preferred.
• Oncology clinical research experience preferred.

Responsibilities

• Set-up, document collection/upload of files to the TMF/eTMF.
• Perform initial quality review of documents prior to upload/filing in the TMF/eTMF.
• Partner with document specialist to maintain the TMF in “audit ready” condition from study start to completion.
• Assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial.
• Proactively liaise with Clinical Research Associate and investigative sites to resolve outstanding regulatory issues.
• Review study documents to ensure they are current, complete and accurate.

Education

High School Diploma or GED

Job description

Sarah Cannon Research Institute (SCRI) is seeking a Clinical Project Associate to ensure TMF setup and audit-ready maintenance throughout studies, in line with GCP, ICH, FDA regulations, and SCRI SOPs. You will support TMF/eTMF processes and track deliverables with cross-functional teams.

Remote-based in the United States, the role requires basic clinical research experience; oncology trials are preferred. Relocation or visa sponsorship are not available.