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Trial Master File Associate Jobs in Raleigh, NC (NOW HIRING)

IQVIA

Clinical Trial Assistant

Durham, NC · On-site

$34K - $118K/yr

Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File ...

CPC

Be Seen First

Clinical Trials Project Manager II - remote

Raleigh, NC · Remote

$72K - $95K/yr

Provide Head of Trial Master File scope of services to enable him/her to establish and maintain ... Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate ...

Fortrea

Clinical Trials Associate I

Durham, NC

$30.25 - $41.50/hr

Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC ... Bachelor's degree in the life sciences or related field; or Associates degree in the life sciences ...

Fortrea

Clinical Trials Associate I

Durham, NC

$32.25 - $44.25/hr

Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC ... Bachelor's degree in the life sciences or related field; or Associates degree in the life sciences ...

IQVIA

Sr. Clinical Research Associate, IQVIA

Durham, NC · On-site

$101K - $169K/yr

IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

IQVIA

Clinical Research Associate 2, IQVIA

Durham, NC · On-site

$71K - $189K/yr

IQVIA is hiring a Clinical Research Associate 2 with on-site monitoring experience in IM/GI, MASH ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

IQVIA

Clinical Research Associate 2, IQVIA

Durham, NC

$71K - $189K/yr

IQVIA is hiring a Clinical Research Associate 2 with on-site monitoring experience in IM/GI, MASH ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

IQVIA

Clinical Research Associate

Durham, NC

$87K - $182K/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 ...

IQVIA

Clinical Research Associate

Durham, NC

$71K - $189K/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 ...

IQVIA

Clinical Research Associate 2, IQVIA

Durham, NC · On-site

$71K - $189K/yr

IQVIA is hiring a Clinical Research Associate 2 with on-site monitoring experience in CNS, GLP-1 ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

Syneoshealth

CTM - Future Roles (US)

Morrisville, NC

Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ... For Real World Late Phase, the CRA I will use the business card title of Site Management Associate ...

IQVIA

Clinical Research Associate 2, IQVIA

Durham, NC

$71K - $189K/yr

IQVIA is hiring a Clinical Research Associate 2 with on-site monitoring experience in CNS, GLP-1 ... Ensure copies/originals (as required) site documents are available for filing in the Trial Master ...

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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.
What are the most commonly searched types of Trial Master File jobs in Raleigh, NC? The most popular types of Trial Master File jobs in Raleigh, NC are:
What are popular job titles related to Trial Master File Associate jobs in Raleigh, NC? For Trial Master File Associate jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Trial Master File Associate jobs in Raleigh, NC look for? The top searched job categories for Trial Master File Associate jobs in Raleigh, NC are:
Trial Master File Associate jobs near you
Clinical Trial Assistant

Clinical Trial Assistant

IQVIA

Durham, NC • On-site

$34K - $118K/yr

Full-time

Posted 7 days ago

IQVIA rating

8.2

Company rating: 8.2 out of 10

Based on 52 frontline employees who took The Breakroom Quiz

45th of 204 rated it services

Job description

Essential Functions
Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Assist with periodic review of study files for completeness.
Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Qualifications
Bachelor's DegreeRequired
3 years administrative support experience.
Equivalent combination of education, training and experience.
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
Written and verbal communication skills including good command of English language.
Effective time management and organizational skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
Knowledge of applicable protocol requirements as provided in company training.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $34,400.00 - $118,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

What IQVIA employees say

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Hours and flexibility

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About IQVIA

Sourced by ZipRecruiter

At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Durham, NC, US

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