Remote TMF Specialist — Clinical Trials

Sarah Cannon Research Institute; United States; Remote; USD 55,000 - 85,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is seeking a Clinical Project Associate for a remote US-based role. You will ensure the Trial Master File (TMF) is set up and maintained in audit-ready condition and conduct critical documentation collection and review throughout the lifecycle of the study in line with GCP, ICH and FDA guidance.

The role includes TMF maintenance, site qualification support, and cross-functional collaboration.

Qualifications

• Minimum High School Diploma or GED.
• 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 and maintain the TMF/eTMF and ensure audit readiness.
• Perform initial quality review of documents prior to upload.
• Partner with document specialists to maintain the TMF from start to completion.
• Assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial.
• Distribute and collect documents from investigative sites; proactively liaise with Clinical Research Associate and sites to resolve outstanding regulatory issues.
• Review study documents to ensure they are current, complete and accurate.
• Other duties as assigned.

Skills

Clinical research experience

Oncology clinical research experience

Education

High School Diploma or GED

Job description

Sarah Cannon Research Institute (SCRI) is seeking a Clinical Project Associate for a remote US-based role. You will ensure the Trial Master File (TMF) is set up and maintained in audit-ready condition and conduct critical documentation collection and review throughout the lifecycle of the study in line with GCP, ICH and FDA guidance.

The role includes TMF maintenance, site qualification support, and cross-functional collaboration.