Sponsor TMF Associate Contract – Oncology Studies – Remote, ET/CT

Category: TMF Associates
Job #: 10913
Utilization: 100%
Location: ET or CT Timezones in US
Job Type: 1099
Therapeutics: No Specific TA Required

Our Sponsor is seeking experienced and motivated TMF Associates to support the organization and maintenance of high-quality Trial Master Files (TMFs) across oncology studies! In this role, you’ll partner closely with the Associate Director of Clinical Business Operations, TMF Specialists, and CRAs to keep study documentation inspection-ready and compliant from start to finish. It’s a great opportunity for someone who thrives on details, collaboration, and contributing to meaningful oncology research.

We can also consider experienced CRAs for this role—as long as they’re able to lock in at the rate and commit to a one-year contract.

If you’re dedicated to quality, teamwork, and advancing clinical research, apply below!

Job Responsibilities:
  • Take charge of keeping Trial Master Files (TMFs) well-organized, accurate, and complete to ensure they’re always ready for inspections.
  • Partner with the TMF Process Owner to spot and address any recurring issues or quality concerns early on.
  • Help design and update project-specific TMF plans and file structures as needed to support smooth workflows.
  • Join system testing efforts and work hand-in-hand with IT to ensure all TMF software tools are properly validated.
  • Collaborate closely with Clinical Operations and Regulatory Affairs teams to keep TMF practices aligned with compliance requirements.
  • Serve as the go-to contact between Site IRBs and the study team to quickly resolve any questions related to IRB documents.
  • Regularly update the study team on TMF progress, focusing especially on how site documentation is tracking.
  • Provide solid support during audits by gathering and sharing requested TMF documents efficiently.
  • Assist with investigating any TMF discrepancies and keep an eye on corrective actions to resolve compliance issues.
  • Oversee CRO contributions to TMFs and make sure final file transfers are complete and ready for regulatory review.
  • Promote and lead best practices to maintain strong TMF quality and integrity across the team.
  • Bring in your good understanding of clinical trials to maintain clear, organized, and audit-ready study records.
  • Thrive in a fast-paced environment by staying organized, juggling priorities well, and contributing as an effective team player.
Job Qualifications:
  • BA/BS degree in any field
  • Minimum of 3 years of clinical research experience (academic or industry)
  • At least 1 year of eTMF administration (Veeva Vault preferred)
  • Strong Microsoft Office skills
  • Solid understanding of GCP, GDP, and ICH guidelines
  • Located in the U.S., EST or CST time zone
  • 100% utilization required (40 hours a week)
  • You will be more competitive if you have an Oncology study background and/or if you are a Boston-based candidate
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