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Entry Level Trial Master File Specialist Jobs (NOW HIRING)

Verastem

Clinical Trial Manager

Boston, MA

$100K - $125K/yr

Assume responsibility for setting up trial master file and ensuring the trial(s) is "audit ready" at all times. * Review, complete and ensure implementation of corrective action plans in conjunction ...

Integrated Resources INC

Participate in continued security and maintenance of the Trial Master File (TMF) Room. * Participate in offsite storage activates. * Create and maintain study specific file structures for Gilead ...

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How much do entry level trial master file specialist jobs pay per hour?

As of Aug 18, 2026, the average hourly pay for entry level trial master file specialist in the United States is $20.24, according to ZipRecruiter salary data. Most workers in this role earn between $16.35 and $21.88 per hour, depending on experience, location, and employer.

What is an entry level trial master file specialist?

An Entry Level Trial Master File (TMF) Specialist is responsible for organizing, maintaining, and ensuring the accuracy and completeness of clinical trial documentation. They work closely with clinical research teams to manage essential documents required by regulatory authorities throughout the lifecycle of a clinical trial. This role is crucial for compliance and helps ensure that all trial documentation is audit-ready and meets industry standards. Entry level specialists typically handle document filing, tracking, quality control checks, and support for audits or inspections.

What are the key skills and qualifications needed to thrive as an entry level trial master file specialist, and why are they important?

To thrive as an Entry Level Trial Master File Specialist, you need strong organizational skills, attention to detail, and a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management tools, and Good Clinical Practice (GCP) guidelines is typically required. Effective communication, time management, and a proactive attitude help you excel in maintaining documentation accuracy and supporting clinical teams. These skills are crucial for ensuring regulatory compliance and smooth clinical trial operations.

What are some common challenges faced by entry level trial master file specialists, and how can they overcome them?

Entry Level Trial Master File (TMF) Specialists often encounter challenges such as managing large volumes of clinical trial documents, ensuring compliance with strict regulatory guidelines, and maintaining accurate records in a fast-paced environment. To overcome these challenges, it's important to develop strong organizational skills, become familiar with relevant regulations like ICH-GCP, and proactively communicate with team members to clarify document requirements. Utilizing available training resources and seeking mentorship from experienced colleagues can also help new specialists adapt quickly and succeed in their role.

What is the difference between Entry Level Trial Master File Specialist vs Clinical Trial Coordinator?

AspectEntry Level Trial Master File SpecialistClinical Trial Coordinator
Primary ResponsibilitiesManaging and organizing trial master files, ensuring document complianceOverseeing trial operations, coordinating site activities, and managing schedules
Required CredentialsHigh school diploma or equivalent; some roles may prefer a degree in life sciencesBachelor's degree in life sciences or related field
Work EnvironmentOffice-based, working with regulatory documents and electronic systemsOffice and site visits, interacting with study teams and sites
Industry UsageCommonly used in clinical research organizations and pharmaceutical companiesUsed across clinical research sites and sponsor companies

While both roles support clinical trials, the Entry Level Trial Master File Specialist focuses on document management and compliance, whereas the Clinical Trial Coordinator handles overall trial operations and site coordination. Understanding these differences helps candidates choose the right career path in clinical research.

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Entry Level Trial Master File Specialist jobs near you
Infographic showing various Entry Level Trial Master File Specialist job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 7% Part Time, 2% Temporary, and 3% Contract. Highlights an 100% In-person job distribution, with an average salary of $42,098 per year, or $20.2 per hour.

In-House Clinical Research Associate

Technical Resources International, Inc

Bethesda, MD • On-site

Full-time

Re-posted 21 days ago

Job description

Job Title
In-House Clinical Research Associate
Location
Bethesda, MD 20817 US (Primary)
Category
Clinical Operations
Job Type
Full-Time
Salary Range
50,000-80,000
Education
Bachelor's Degree
Travel
None
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.
Job Requirements
  • 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.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

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