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Trial Master File Associate Jobs (NOW HIRING)

Crinetics Pharmaceuticals

Clinical Trial Associate

$34.25 - $46.75/hr

The Clinical Trial Associate ("CTA") is a highly skilled specialist contributing to the development ... Maintain the Trial Master File for all clinical projects * Perform periodic reviews and QC of the ...

PTC Therapeutics

Contract, Clinical Trial Associate

Warren, NJ · On-site

$34.75 - $47.50/hr

The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities ...

Medpace, Inc.

Entry-Level TMF Administrator

Cincinnati, OH

$32.25 - $44/hr

The Trial Master File (TMF) is a collection of documents that stores all data and research ... Associates degree, or equivalent; * Some experience in document administration; * High attention to ...

Medpace, Inc.

Entry-Level TMF Administrator

Cincinnati, OH · On-site

$32.25 - $44/hr

The Trial Master File (TMF) is a collection of documents that stores all data and research ... Associates degree, or equivalent; * Some experience in document administration; * High attention to ...

Vanguard Clinical

Clinical Operations Associate (Pool)

CA · Remote

$70K - $80K/yr

... Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study ... Clinical Operations Associate: $70,304 - 80,000 annually + benefits package and annual performance ...

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Trial Master File Associate information

What are some common challenges Trial Master File Associates face when managing clinical trial documentation?

Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.

What are the key skills and qualifications needed to thrive as a Trial Master File Associate, and why are they important?

To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.

What is the difference between Trial Master File Associate vs Clinical Trial Coordinator?

AspectTrial Master File AssociateClinical Trial Coordinator
CertificationsMay require GCP or regulatory document management certificationsOften requires GCP training, clinical research certifications
Work EnvironmentFocuses on document management within clinical trialsOversees trial operations, patient coordination, site management
Industry UsageCommonly used in pharmaceutical and biotech companiesUsed across clinical research sites and CROs

The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.

What is a Trial Master File Associate?

A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.
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Trial Master File Associate jobs near you
Infographic showing various Trial Master File Associate job openings in the United States as of June 2026, with employment types broken down into 66% Full Time, 33% Part Time, and 1% Contract. Highlights an 70% Physical, 6% Hybrid, and 24% Remote job distribution.
Clinical Records Associate

Clinical Records Associate

Integrated Resources INC

Foster City, CA • On-site

Full-time

Posted 29 days ago

Job description

Company Description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Job Title: Clinical Records Associate - II

Location: Foster City, CA

Duration: 12 Months

Job Description:

  • Must meet all requirements for Clinical Records Assistant position and have demonstrated proficiency in all relevant areas.
  • Maintain an understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records.
  • Maintain a working knowledge of clinical, biometrics, and preclinical documents.
  • Participate in continued security and maintenance of the Trial Master File (TMF) Room.
  • Assist in the development and implementation of procedure s for the establishment, security, and maintenance of the Trial Master Files for clinical studies and for preclinical study records.
  • Assist in the development of Trial Master File SOPs.
  • Assist with the training of Client and contract employees on the TMF SOPs.
  • Participate in the management of vendor relationships including offsite storage.
  • Create and maintain study specific file structures for Client clinical, biometrics, and preclinical documents and file documents accordingly.
  • Ensure record filing is kept up to date and is performed accurately.
  • Perform an inventory review for incoming CRO clinical study files; receive, index, and file preclinical study records; responsible for offsite archival of documents; participate in periodic file room utilization reviews; file incoming documents and retrieve documentation from the TMFR upon request.
  • Ensure appropriate documentation completed to track archival of files.
  • May provide support during TMF-related regulatory agency and internal GCP inspections.
  • Assist in the development of electronic tracking/ filing systems.
Additional Information

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Gold Seal JCAHO Certified for Health Care Staffing

"INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)

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About Integrated Resources

Sourced by ZipRecruiter

Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996

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