CRA 2, Oncology, IQVIA
$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 ...
$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 ...
$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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Durham, NC · On-site
$87K - $169K/yr
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 ...
Durham, NC · On-site
$87K - $169K/yr
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 ...
Durham, NC · On-site
$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 ...
Durham, NC · On-site
$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 ...
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 ...
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 ...
Maintain governance and oversee TMF compliance. Strategy & Innovation * Drive adoption of modern technologies, standards, and Agile practices. * Provide technical input on programming strategies and ...
Maintain governance and oversee TMF compliance. Strategy & Innovation * Drive adoption of modern technologies, standards, and Agile practices. * Provide technical input on programming strategies and ...
Durham, NC · On-site
$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 ...
Durham, NC · On-site
$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 ...
Durham, NC · On-site
$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 ...
Durham, NC · On-site
$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 ...
Durham, NC · On-site
$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 ...
Durham, NC · On-site
$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 ...
Maintain governance and oversee TMF compliance. Strategy & Innovation * Drive adoption of modern technologies, standards, and Agile practices. * Provide technical input on programming strategies and ...
Maintain governance and oversee TMF compliance. Strategy & Innovation * Drive adoption of modern technologies, standards, and Agile practices. * Provide technical input on programming strategies and ...
Durham, NC · On-site
$87K - $169K/yr
May support start-up phase. • 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 ...
Durham, NC · On-site
$87K - $169K/yr
May support start-up phase. • 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 ...
Durham, NC · On-site
$71K - $169K/yr
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 ...
Durham, NC · On-site
$71K - $169K/yr
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 ...
Durham, NC · 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 ...
Durham, NC · 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 ...
Durham, NC · On-site
$71K - $169K/yr
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 ...
Durham, NC · On-site
$71K - $169K/yr
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 ...
Durham, NC · On-site
$71K - $119K/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 ...
Durham, NC · On-site
$71K - $119K/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 ...
Durham, NC · On-site
$87K - $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 ...
Durham, NC · On-site
$87K - $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 ...
Durham, NC · On-site
$87K - $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 ...
Durham, NC · On-site
$87K - $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 ...
$71K - $119K/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 ...
$71K - $119K/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 ...
$16.82 - $21.50
4% of jobs
$21.50 - $26.17
8% of jobs
$26.17 - $30.84
12% of jobs
$30.98 is the 25th percentile. Wages below this are outliers.
$30.84 - $35.52
26% of jobs
$35.52 - $40.19
18% of jobs
$41.81 is the 75th percentile. Wages above this are outliers.
$40.19 - $44.86
19% of jobs
$44.86 - $49.54
6% of jobs
$49.54 - $54.21
2% of jobs
$54.21 - $58.88
1% of jobs
$58.88 - $63.56
1% of jobs
$63.56 - $68.23
2% of jobs
$16
$38
$68
To thrive as a TMF (Trial Master File) Specialist, you need a solid understanding of clinical trial documentation, regulatory guidelines (such as ICH-GCP), and strong organizational skills, typically supported by experience in clinical research or a related life sciences field. Proficiency with electronic Trial Master File (eTMF) systems, document management software, and sometimes certifications like DIA TMF or clinical research certification are commonly required. Attention to detail, effective communication, and the ability to manage deadlines are important soft skills in this role. These competencies ensure regulatory compliance, efficient document retrieval, and successful clinical trial audits.
A TMF (Trial Master File) job typically involves managing and maintaining essential documents related to clinical trials. Professionals in this role ensure that all trial documentation complies with regulatory requirements and is audit-ready. They may work with electronic TMF (eTMF) systems, collaborate with study teams, and ensure document accuracy and completeness. TMF specialists play a crucial role in supporting clinical research compliance and regulatory submissions.
As a TMF Specialist, your daily responsibilities include maintaining and updating essential clinical trial documents, ensuring accurate filing and compliance with regulatory standards, and performing routine quality checks on documentation. You will collaborate closely with clinical operations, project managers, and external stakeholders to gather and validate needed materials. Attention to deadlines and meticulous organization are critical, as audits and inspections may require quick access to correctly archived files. This hands-on role is vital for ensuring that all documentation is complete, accurate, and ready for review throughout the life cycle of a clinical trial.

8.2
Based on 52 frontline employees who took The Breakroom Quiz
46th of 206 rated it services
IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience:
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) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP 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.
Education: Bachelor's Degree (Degree in scientific discipline or health care preferred)
Experience: 1.5 to 2 years of relevant CRA experience including on-site monitoring.
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 $87,200.00 - $145,300.00. 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.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.
Health care and social assistance
10,000+ Employees
Durham, NC, US