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 ...
$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 ...
$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 ...
$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 ...
$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 ...
$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 ...
$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 ...
$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 ...
$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 ...
$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 ...
$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 ...
$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 - $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 ...
$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 ...
Houston, TX · On-site
$71K - $145K/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 ...
Houston, TX · On-site
$71K - $145K/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 ...
$71K - $145K/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 ...
$71K - $145K/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 ...
$71K - $145K/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 ...
$71K - $145K/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 ...
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 ...
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 ...
$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 ...
$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 ...
$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 ...
$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 ...
$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 ...
$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 ...
Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times. * Maintain accurate and up-to date study tracking ...
Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times. * Maintain accurate and up-to date study tracking ...
Houston, TX · Remote
$120K/yr
Grow into a high-level litigator and trial attorney * Help build a modern law firm that is ... Handle injury cases from filing through resolution * Draft pleadings, motions, and discovery * Take ...
Houston, TX · Remote
$120K/yr
Grow into a high-level litigator and trial attorney * Help build a modern law firm that is ... Handle injury cases from filing through resolution * Draft pleadings, motions, and discovery * Take ...
Upon completion of your probationary/trial period, your employment will be terminated unless you ... Successfully completed a Master's or equivalent graduate degree or 2 full years of progressively ...
Upon completion of your probationary/trial period, your employment will be terminated unless you ... Successfully completed a Master's or equivalent graduate degree or 2 full years of progressively ...
To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.
A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.
As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.
8.2
Based on 52 frontline employees who took The Breakroom Quiz
46th of 204 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