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

IQVIA

Associate Scientist, Laboratory Operations

Durham, NC · On-site

$42K - $89K/yr

We are seeking Associate Scientist, Laboratory Operations to join IQVIA Laboratories at Durham, NC ... Experience with Trial Master File maintenance, clinical documentation, Case Report Forms, queries ...

Fortrea

TMF Lead II - FSP - US

Durham, NC · On-site

$30.25 - $41.50/hr

The TMF Management team is responsible for the completeness and accuracy of the Trial Master File (TMF) for all sponsored studies. The TMF Lead II is the Subject Matter Expert for TMF across all ...

Fortrea

TMF Lead II - FSP - US

Durham, NC · Remote

$32.25 - $44.25/hr

The TMF Management team is responsible for the completeness and accuracy of the Trial Master File (TMF) for all sponsored studies. The TMF Lead II is the Subject Matter Expert for TMF across all ...

Veranex

Sr Clinical Research Associate

Raleigh, NC · On-site

$98K - $140K/yr

Veranex has an exciting opportunity to join our team as a Senior Clinical Research Associate to ... trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory ...

Aerogen Ltd

Clinical Trial Manager

Morrisville, NC · On-site

... in the Trial Master File to ensure inspection readiness. • Assist in the development of study documents and tools including informed consent forms, project plans, budgets, logs, templates ...

System One

Clinical Study Manager

Durham, NC · On-site

... the Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. * Draft, review, and/or approve study-related documents, including ...

System One

Clinical Study Manager

Durham, NC · On-site

... the Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. * Draft, review, and/or approve study-related documents, including ...

System One

Clinical Study Manager

Durham, NC · On-site

... the Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. * Draft, review, and/or approve study-related documents, including ...

System One

Clinical Study Manager

Durham, NC · On-site

... the Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. * Draft, review, and/or approve study-related documents, including ...

System One

Clinical Study Manager

Durham, NC · On-site

... the Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. * Draft, review, and/or approve study-related documents, including ...

System One

Clinical Study Manager

Durham, NC · On-site

... the Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities. * Draft, review, and/or approve study-related documents, including ...

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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?

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

Associate Scientist, Laboratory Operations

IQVIA

Durham, NC • On-site

$42K - $89K/yr

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

IQVIA rating

8.1

Company rating: 8.1 out of 10

Based on 53 frontline employees who took The Breakroom Quiz

59th of 221 rated it services

Job description

We are seeking Associate Scientist, Laboratory Operations to join IQVIA Laboratories at Durham, NC.
We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.
Job Summary:
Perform routine laboratory analysis and testing procedures while supporting accurate documentation, study file maintenance, and Trial Master File delivery. Assist clinical and regulatory teams with documentation, systems updates, tracking activities, and project communications to support compliant study execution.
What You'll Be Doing:
  • Perform routine analysis and laboratory testing procedures to obtain data from client specimens
  • Provide timely documentation and review of work performed in accordance with applicable procedures
  • Assist Clinical Research Associates and Regulatory and Start-Up teams with updating and maintaining clinical documents and systems, including the Trial Master File
  • Support preparation, handling, distribution, filing, and archiving of clinical documentation and reports
  • Assist with periodic review of study files for completeness
  • Coordinate tracking and management of Case Report Forms, queries, clinical data flow, and clinical trial supplies
  • Serve as a central contact for designated project communications, correspondence, and associated documentation
  • Complete various laboratory tasks including inventory, equipment maintenance, general maintenance logs, cell culture, assay training, data compilation, and scheduling support
What We Are Looking For:
  • High School Diploma or equivalent required
  • Years of experience in relevant fields - 3-4 years administrative support experience
  • Minimum one year clinical research experience strongly preferred
  • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
  • Basic knowledge of applicable clinical research regulatory requirement, i.e., Good Clinical Practice and International Conference on Harmonization guidelines as provided in company training
  • Knowledge of applicable protocol requirements as provided in company training
  • Experience with Trial Master File maintenance, clinical documentation, Case Report Forms, queries, and clinical data flow tracking
  • Other equivalent combination of education, training, and experience may be accepted in lieu of degree
The Knowledge, Skills and Abilities Needed for This Role:
  • 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
  • Strong attention to detail when reviewing, filing, archiving, and maintaining study documentation
  • Ability to support multiple project communications, documentation workflows, and laboratory operations activities within project timelines
What We Offer You:
We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees' physical, mental and emotional, financial and social well-being so they can thrive at home and at work, at any stage of their well-being journey.
To learn more about our benefits, visit IQVIA benefits.
If you're looking to unleash your potential, join IQVIA Laboratories to help make the extraordinary possible!

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 $42,700.00 - $89,000.00. 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.

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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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