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Trial Master File Associate Jobs (NOW HIRING)

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 ...

Sitero LLC

Lead Clinical Trial Associate

Coral Gables, FL · Hybrid

$32 - $43.75/hr

Lead Clinical Trial Associate Location: 3 days per week in our Coral Gables, Florida office. 2 days ... Master File (TMF) documents and site-related data in applicable clinical systems per record ...

New

Sitero LLC

Lead Clinical Trial Associate

Miami, FL · On-site

Lead Clinical Trial Associate Location: 3 days per week in our Coral Gables, Florida office. 2 days ... Master File (TMF) documents and site-related data in applicable clinical systems per record ...

New

Sitero LLC

Lead Clinical Trial Associate

Coral Gables, FL · On-site

$70K - $80K/yr

Lead Clinical Trial Associate Location: 3 days per week in our Coral Gables, Florida office. 2 days ... Master File (TMF) documents and site-related data in applicable clinical systems per record ...

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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 July 2026, with employment types broken down into 1% As Needed, 67% Full Time, 30% Part Time, 1% Temporary, and 1% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution.
Clinical Research Documentation Administrator (TMF)

Clinical Research Documentation Administrator (TMF)

Medpace, Inc.

Cincinnati, OH • On-site

$32.25 - $44/hr

Other

Medical, PTO

Re-posted 19 days ago

Medpace rating

8.5

Company rating: 8.5 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

14th of 59 rated research

Job description

Job Summary
We are currently hiring individuals seeking an exciting career in clinical research, managing our Trial Master File. The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device receiving approval by the FDA. In this position, you will be working with a highly experienced team of other administrators and clinical research professionals that can help you grow your skillset while working for a growing and developing company. *This position is fully office-based in Cincinnati, OH.
Responsibilities
The Clinical Research Documentation Coordinator supports TMF oversight for a trial by ensuring documents meet established quality standards. This position involves both independent and computer-based work, as well as opportunity for communication and collaboration with trial teams.
  • Manage electronic filing system for trial documentation;
  • Track, maintain, and perform quality check of electronic documents;
  • Communicate with internal associates globally regarding errors in trial documents; and
  • Prepare documents for shipment.

Qualifications
  • Associates degree, or equivalent required;
  • Bachelor's degree preferred;
  • Some experience in document administration;
  • High attention to detail;
  • Excellent organizational skills
  • Strong written and verbal communication skills; and
  • Knowledge of MS Office.

Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
  • Flexible work environment
  • Competitive PTO packages, starting at 20+ days
  • Competitive compensation and benefits package
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Community involvement with local nonprofit organizations
  • Discounts on local sports games, fitness gyms and attractions
  • Modern, ecofriendly campus with an on-site fitness center
  • Structured career paths with opportunities for professional growth
  • Discounted tuition for UC online programs

Awards
  • Named a Top Workplace in 2024 by The Cincinnati Enquirer
  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

What Medpace employees say

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About Medpace

Sourced by ZipRecruiter

Medpace is a globally recognized clinicial contract research organization (CRO) based in Cincinnati, OH, in the United States. Established in 1992, it operates in the healthcare sector, providing scientifically-driven outsourcing solutions for the development of drugs and medical devices. It offers comprehensive services like full-service clinical development services, regulatory affairs management, clinical pharmacology, data management, statistical analysis, and medical writing. By applying a scientifically-driven, therapeutically-focused, and patient-centric approach, Medpace's mission is to accelerate the global development of safe and effective medical therapies.

Industry

Medical equipment and supplies manufacturing

Company size

1,001 - 5,000 Employees

Headquarters location

Cincinnati, OH, US

Year founded

1992

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