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 ...
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 ...
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 ...
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 ...
In-House CRA / Clinical Trial Associate
$34.25 - $46.75/hr
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
In-House CRA / Clinical Trial Associate
$34.25 - $46.75/hr
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
In-House CRA / Clinical Trial Associate
Rockville, MD ยท On-site
$34.25 - $46.75/hr
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
In-House CRA / Clinical Trial Associate
Rockville, MD ยท On-site
$34.25 - $46.75/hr
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
Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to ...
Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), 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 Sponsor/Client.
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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 Sponsor/Client.
New
Draft, review, and maintain clinical trial forms (e.g., eligibility forms, FAQs/Medical Monitoring Logs, Medical Review Summary Forms) and file them in appropriate folders (e.g., Trial Master File ...
Draft, review, and maintain clinical trial forms (e.g., eligibility forms, FAQs/Medical Monitoring Logs, Medical Review Summary Forms) and file them in appropriate folders (e.g., Trial Master File ...
Sr. Clinical Research Associate, IQVIA
Rockville, MD ยท On-site
$101K - $169K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Sr. Clinical Research Associate, IQVIA
Rockville, MD ยท On-site
$101K - $169K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Sr. Clinical Research Associate, IQVIA
Fairfax, VA ยท On-site
$101K - $169K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Sr. Clinical Research Associate, IQVIA
Fairfax, VA ยท On-site
$101K - $169K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Senior Clinical Data Manager
Rockville, MD ยท On-site
Collaborate with Document Management team to archive DM-related documents in Trial Master File (TMF). * Write DM-related SOPs and/or Job aids and contribute to improving DM processes. Non-Essential ...
Senior Clinical Data Manager
Rockville, MD ยท On-site
Collaborate with Document Management team to archive DM-related documents in Trial Master File (TMF). * Write DM-related SOPs and/or Job aids and contribute to improving DM processes. Non-Essential ...
Litigation Paralegal
Washington, DC ยท Hybrid
Maintain correspondence and pleadings, master file index and deposition files and database, Monitor ... trial preparation, manage trial exhibits, prepare notebooks, maintain expert binders, travel to ...
New
Litigation Paralegal
Washington, DC ยท Hybrid
Maintain correspondence and pleadings, master file index and deposition files and database, Monitor ... trial preparation, manage trial exhibits, prepare notebooks, maintain expert binders, travel to ...
New
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
Fairfax, VA ยท On-site
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
Fairfax, VA ยท On-site
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the ...
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local ...
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local ...
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local ...
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local ...
Senior Litigation Paralegal
Washington, DC ยท On-site
... filings. Organizing and managing electronic and hard copy document collections. Managing and ... Trial preparation and attendance. Supervise junior paralegals and litigation teams. Prioritize and ...
Senior Litigation Paralegal
Washington, DC ยท On-site
... filings. Organizing and managing electronic and hard copy document collections. Managing and ... Trial preparation and attendance. Supervise junior paralegals and litigation teams. Prioritize and ...
Clinical Trial Biostatistician
Bethesda, MD ยท On-site
... filing and study close-out. This is a fractional, deliverable-driven role with workload ... Master's degree in Biostatistics, Statistics, or closely related quantitative field (or equivalent ...
Clinical Trial Biostatistician
Bethesda, MD ยท On-site
... filing and study close-out. This is a fractional, deliverable-driven role with workload ... Master's degree in Biostatistics, Statistics, or closely related quantitative field (or equivalent ...
... filing and study close-out. This is a fractional, deliverable-driven role with workload ... Master's degree in Biostatistics, Statistics, or closely related quantitative field (or equivalent ...
... filing and study close-out. This is a fractional, deliverable-driven role with workload ... Master's degree in Biostatistics, Statistics, or closely related quantitative field (or equivalent ...
Trial Master File information
See Washington salary details
$12.39 - $18.84
4% of jobs
$18.84 - $25.29
9% of jobs
$28.59 is the 25th percentile. Wages below this are outliers.
$25.29 - $31.75
24% of jobs
The median wage is $37.51 / hr.
$31.75 - $38.20
15% of jobs
$38.20 - $44.65
16% of jobs
$49.01 is the 75th percentile. Wages above this are outliers.
$44.65 - $51.10
11% of jobs
$51.10 - $57.55
10% of jobs
$57.55 - $64.01
8% of jobs
$64.01 - $70.46
0% of jobs
$70.46 - $76.91
2% of jobs
$76.91 - $83.36
2% of jobs
$12
$42
$83
How much do trial master file jobs pay per hour?
What are the key skills and qualifications needed to thrive in the trial master file position, and why are they important?
To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.
What is a trial master file?
A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.
What are the typical responsibilities and daily tasks of a trial master file specialist?
As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.

Full-time
Re-posted 8 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.