Remote TMF Quality Assurance Associate

Sarah Cannon Research Institute

Nashville (TN)

Remote

USD 60,000 - 90,000

Full time

7 days ago
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Job summary

Sarah Cannon Research Institute (SCRI) is seeking a Clinical Project Associate to ensure the Trial Master File is set up and maintained in audit-ready condition. You will manage TMF/eTMF document collection and perform quality reviews throughout the trial lifecycle.

Role involves coordinating with investigators, sites, and cross-functional teams to ensure timely delivery of study documents and regulatory compliance.

Qualifications

  • High School Diploma or GED required.
  • 1 year of clinical research experience required; 3 years preferred.
  • Oncology clinical research experience preferred.

Responsibilities

  • Set up and maintain the TMF/eTMF in audit-ready condition.
  • Perform initial quality review of documents prior to upload.
  • Collaborate with document specialists to maintain TMF/eTMF from study start to completion.
  • Assist with verifying qualifications of investigators and sites during the trial.
  • Distribute and collect essential trial documents with sites and resolve regulatory issues.
  • Review study documents to ensure currency and completeness.

Skills

Clinical research experience
Oncology experience

Education

High School Diploma or GED

Job description

Sarah Cannon Research Institute (SCRI) is seeking a Clinical Project Associate to ensure the Trial Master File is set up and maintained in audit-ready condition. You will manage TMF/eTMF document collection and perform quality reviews throughout the trial lifecycle.

Role involves coordinating with investigators, sites, and cross-functional teams to ensure timely delivery of study documents and regulatory compliance.

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