CRA Specialist I

1 week ago

Raleigh NC, United States Actalent Full time

Job Title: TMF Specialist
To maintain continuity and compliance across ongoing medical device trials, we are seeking a TMF Specialist to provide dedicated support and ensure the integrity of trial documentation.
Maintain and oversee the Trial Master File (TMF) for active medical device studies, ensuring completeness, accuracy, and inspection readiness.
• Partner closely with Clinical Project Managers, CRAs (site monitors), and Data Managers to ensure all essential documents are collected, filed, and reconciled in accordance with ICH GCP and FDA regulations.
• Track document flow and proactively identify gaps or inconsistencies, escalating issues to project leadership as needed.
• Serve as the central point of contact for TMF related queries between sponsors, CROs, sites, and regulatory bodies.
• Support audits and inspections by preparing TMF documentation and ensuring compliance with post market IDE exempt requirements.
• 5+ years’ experience managing TMFs in support of medical device trials.
• o This includes experience supporting studies involving marketed devices that don’t require FDA IDE approval, with a focus on surveillance, registries, or observational data collection.
• Proven ability to collaborate cross functionally with CPMs, CRAs, and Data Managers to ensure documentation supports patient safety, regulatory compliance, and reliable trial outcomes.
This role currently designated as 100% Remote/ Homebased.
This is a Contract position based out of Raleigh, NC.
If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Application Deadline
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. xrczosw With a network of almost 30,000 consultants and more than 4,500 clients across the U.Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.

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