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Trial Master File Associate Jobs in Ashburn, VA (NOW HIRING)

REGENXBIO

In-House CRA / Clinical Trial Associate

Rockville, MD · On-site

$34.25 - $46.75/hr

  • Retirement

Assists with filing and management of the Electronic Trial Master File (eTMF) * Distributes meeting's agenda, prepare and distributes final meeting minutes including documentation of action items

REGENXBIO

In-House CRA / Clinical Trial Associate

Rockville, MD · On-site

$34.25 - $46.75/hr

  • Retirement

Assists with filing and management of the Electronic Trial Master File (eTMF) * Distributes meeting's agenda, prepare and distributes final meeting minutes including documentation of action items

MacroGenics, Inc.

Sr. TMF Manager

Rockville, MD · On-site

$34.25 - $46.75/hr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Summary of Position This position provides TMF expertise and leads a cross-functional team in all aspects of management of the trial master file set up, design, and oversight. Responsibilities ...

MacroGenics

Sr. TMF Manager

Rockville, MD · On-site

$34.25 - $46.75/hr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Summary of Position This position provides TMF expertise and leads a cross-functional team in all aspects of management of the trial master file set up, design, and oversight. Responsibilities ...

Emmes

Sr. In-House CRA

Rockville, MD · On-site +1

  • Medical

  • Retirement

The Senior In-House Clinical Research Associate (CRA) is responsible for assisting with operational ... Performs upload of essential documents into the trial master file. * Independently communicates and ...

IQVIA

MedTech Site Manager 1

Washington, DC

$74K - $124K/yr

Position Overview The In-House Clinical Research Associate/MedTech Site Manager 1 will be a ... Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist ...

New

IQVIA

MedTech Site Manager 1

Washington, DC · On-site

$74K - $124K/yr

Position Overview The In-House Clinical Research Associate/MedTech Site Manager 1 will be a ... Ensure Trial Master File is accurate and complete throughout the lifecycle of the project. * Assist ...

New

IQVIA

CRA 1, IQVIA Biotech

Rockville, MD

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

IQVIA

CRA 1, IQVIA Biotech

Fairfax, VA

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

IQVIA

CRA 1, IQVIA Biotech

Rockville, MD

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

IQVIA

CRA 1, IQVIA Biotech

Fairfax, VA

$71K - $145K/yr

Job Overview The Clinical Research Associate I (CRA I) plays a key role in supporting the ... the Trial Master File (TMF) and the Investigator Site File (ISF). A central part of this role ...

MELEHY AND ASSOCIATES LLC

Associate Attorney

Silver Spring, MD · On-site

$75K - $120K/yr

  • Retirement

  • PTO

... trial advocacy. Candidates must be members of both the Maryland and D.C. bars, or be eligible to ... file (subject line: Associate Attorney Application - Your Name) in an email addressed to: Pablo ...

MELEHY AND ASSOCIATES LLC

Associate Attorney

Silver Spring, MD · On-site

$75K - $120K/yr

  • Retirement

  • PTO

... trial advocacy. Candidates must be members of both the Maryland and D.C. bars, or be eligible to ... file (subject line: Associate Attorney Application - Your Name) in an email addressed to: Pablo ...

MELEHY AND ASSOCIATES LLC

Associate Attorney

Silver Spring, MD · On-site

$75K - $120K/yr

  • Retirement

  • PTO

... trial advocacy. Candidates must be members of both the Maryland and D.C. bars, or be eligible to ... file (subject line: Associate Attorney Application - Your Name) in an email addressed to: Pablo ...

Keller Postman

Associate

Washington, DC · On-site

This individual will work closely with experienced trial lawyers on high-impact cases that make a ... files, and investigatory materials Draft pleadings, motions, discovery requests/responses, and ...

Keller Postman

Associate

Washington, DC · On-site

This individual will work closely with experienced trial lawyers on high-impact cases that make a ... files, and investigatory materials • Draft pleadings, motions, discovery requests/responses, and ...

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All JobsTrial Master File Associate JobsTrial Master File Associate Jobs in Ashburn, VA

Trial Master File Associate information

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.

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

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 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 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 are the most commonly searched types of Trial Master File jobs in Ashburn, VA?

The most popular types of Trial Master File jobs in Ashburn, VA are:

What are popular job titles related to Trial Master File Associate jobs in Ashburn, VA?

For Trial Master File Associate jobs in Ashburn, VA, the most frequently searched job titles are:

What job categories do people searching Trial Master File Associate jobs in Ashburn, VA look for?

The top searched job categories for Trial Master File Associate jobs in Ashburn, VA are:

Trial Master File Associate jobs near you
Infographic showing various Trial Master File Associate job openings in Ashburn, VA as of August 2026, with employment types broken down into 72% Full Time, and 28% Contract. Highlights an 67% In-person, and 33% Remote job distribution.

In-House Clinical Research Associate

TRI Challenge Convention

Bethesda, MD • Hybrid

Full-time

Re-posted 21 days ago

Job description

The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties. Duties may include but are not limited to: Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system held by TRI or Sponsor/Client. Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs.

Track essential regulatory documents in a centralized web-based system and/or other database. Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems. Coordinate or assist in distribution of trial-related materials to study sites.

May assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation. NOTE: Specialized experience in eTMF (e.g., Veeva Vault) processing and system administration skills-sets and/or additional responsibilities may be required for some staff. This job may serve as a transition or training role for the position of field CRA, as appropriate.Understanding of medical and clinical trials terminology

Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution. Able to work independently or with minimal supervision as well as within a team. Excellent attention to detail with organizational and prioritization skills for efficient productivity.

Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum). Excellent professional writing and verbal communication skills (position requires clear phone and email communication). Able to multi-task during the review/processing and preparation of essential regulatory documentation.

Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right. Must have excellent time management skills, able to adhere to strict timelines and expectations. Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus.

Experience with using a Trial Master File, a plus. This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.Understanding of medical and clinical trials terminology. Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution

Able to work independently or with minimal supervision as well as within a team. Excellent attention to detail with organizational and prioritization skills for efficient productivity. Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum).

Excellent professional writing and verbal communication skills (position requires clear phone and email communication). Able to multi-task during the review/processing and preparation of essential regulatory documentation. Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right.

Must have excellent time management skills, able to adhere to strict timelines and expectations. Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus. Experience with using a Trial Master File, a plus.

This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.

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