ZipRecruiter

Log In

1

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

IQVIA

Clinical Research Associate, Full Service

Durham, NC · On-site

$47K - $169K/yr

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH ...

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 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

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

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 1, IQVIA Biotech

Durham, NC

$71K - $145K/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, Inc.

CRA 1, IQVIA Biotech

Durham, NC · On-site

$71K - $145K/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 ...

next page

Showing results 1-20

All JobsTrial Master File Associate JobsTrial Master File Associate Jobs in Raleigh, NC

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, Sponsor Dedicated

Clinical Research Associate, Sponsor Dedicated

IQVIA, Inc.

Durham, NC • On-site

$64K - $189K/yr

Full-time

Posted 16 days ago

IQVIA rating

8.1

Company rating: 8.1 out of 10

Based on 53 frontline employees who took The Breakroom Quiz

56th of 210 rated it services

Job description

To be eligible for this position, you must reside in the same country where the job is located.
Seeking experienced candidates near major hub airports in the Southeast, Northeast, Central and West regions.
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Position requires 65-70% nationwide travel.
Essential Functions
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
MINIMUM RECRUITMENT STANDARDS:
  • 2.5 years of clinical research coordination experience at site level
  • Nursing or University Degree (US Bachelor Level or equivalent) in one of the life sciences
  • Knowledge of electronic data capture preferred
  • Equivalent combination of education, training and experience

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 at https://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 $64,000.00 - $189,000.00. 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.

What IQVIA employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

IQVIA logo

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

View All IQVIA Jobs

Apply