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

IQVIA

Clinical Research Associate, IQVIA Biotech

Durham, NC · On-site

$71K - $169K/yr

Job Overview We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play ... Ensure that essential documents are collected and maintained in both the Trial Master File (TMF ...

IQVIA

CRA 2, Oncology, IQVIA

Durham, NC · On-site

$87K - $145K/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, Inc.

CRA 1, IQVIA Biotech

Durham, NC · On-site

$71K - $119K/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

Durham, NC · On-site

$71K - $119K/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

Durham, NC

$71K - $119K/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 ...

CTI

Clinical Project Coordinator

Raleigh, NC · On-site

Support and maintain clinical project documents in paper and/or electronic Trial Master Files and ... Research Associates (RAs) in clinical projects * Assist with orientating new Clinical staff

New

PSI CRO

Site Management Associate II

Durham, NC

Under supervision, provides on-the-job coaching of Site Management Associates I and Clinical ... Files trial records in the TMF and performs regular TMF checks on a site and country level

PSI CRO

Site Management Associate II

Durham, NC

Under supervision, provides on-the-job coaching of Site Management Associates I and Clinical ... Files trial records in the TMF and performs regular TMF checks on a site and country level

PSI CRO

Site Management Associate II

Durham, NC · On-site

Under supervision, provides on-the-job coaching of Site Management Associates I and Clinical ... Files trial records in the TMF and performs regular TMF checks on a site and country level

PSI CRO

Site Management Associate II

Durham, NC

Under supervision, provides on-the-job coaching of Site Management Associates I and Clinical ... Files trial records in the TMF and performs regular TMF checks on a site and country level

McIlveen Family Law Firm

Associate Attorney

Raleigh, NC · On-site

$100K - $140K/yr

We are looking for a motivated Attorney with exceptional trial, negotiation, research, and ... filed, as well as applicable law. * Interpret case law and decisions of other applicable courts.

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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 Research Associate, IQVIA Biotech

Clinical Research Associate, IQVIA Biotech

IQVIA

Durham, NC • On-site

$71K - $169K/yr

Full-time

Posted 5 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

IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring and will also consider CRA 1 candidates with a minimum of 6 months on-site monitoring experience. Must have experience monitoring in oncology solid tumor.

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Job Overview
We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.

Key Responsibilities

  • Conduct all types of site visits-selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.

  • Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.

  • Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.

  • Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.

  • Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.

  • Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.

  • Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.

  • Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.

  • Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Qualifications

  • Bachelor's degree in life sciences or health-related field (or equivalent experience).

  • Requires at least 1 year of on-site monitoring experience.

  • Strong understanding of GCP, ICH guidelines, and regulatory requirements.

  • Ability to travel as required by the project.

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 $71,900.00 - $169,300.00. 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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