Remote TMF & Clinical Trial Documentation Specialist

McKesson’s Corporate; Northern (KY); Hybrid; USD 60,000 - 80,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, is hiring a Clinical Project Associate. The role ensures TMF/eTMF is audit ready and manages critical documentation across the trial lifecycle. You will work with cross‑functional teams to guarantee timely deliverables and maintain regulatory compliance.

This remote‑based position in the US excludes relocation sponsorship. We seek candidates with clinical research experience, with oncology exposure preferred, to support trials across

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, 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.
• Perform critical document distribution to and collection from the investigative sites throughout the lifecycle of the clinical trial.
• Proactively liaise with Clinical Research Associate and investigative site to resolve outstanding regulatory issues.
• Review study documents to ensure they are current, complete and accurate.

Skills

Clinical research experience

Oncology clinical research experience

Education

High School Diploma or GED

Job description

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, is hiring a Clinical Project Associate. The role ensures TMF/eTMF is audit ready and manages critical documentation across the trial lifecycle. You will work with cross‑functional teams to guarantee timely deliverables and maintain regulatory compliance.

This remote‑based position in the US excludes relocation sponsorship. We seek candidates with clinical research experience, with oncology exposure preferred, to support trials across