CRA 2, Oncology

Regulatory Toolkit; Durham (NC); On-site; USD 90,000 - 150,000; Full time

Job summary

IQVIA is seeking a CRA II with 1.5–2 years of on-site oncology monitoring experience in the United States. The role focuses on site monitoring visits, GCP/ICH compliance, and active collaboration with sites to maintain high study quality.

Responsibilities include recruitment planning, protocol training, regulatory submissions tracking, and TMF/ISF management. Bachelor's degree in a scientific field or healthcare is preferred, with potential for start-up support as needed.

Qualifications

• 1.5 to 2 years of CRA experience including on-site monitoring.
• Bachelor’s Degree in scientific discipline or health care preferred.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per contracted scope and GCP/ICH guidelines.
• Drive and track subject recruitment plans to meet project needs.
• Administer protocol training to sites and maintain regular communication to manage expectations and issues.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues as needed.
• Manage progress by tracking regulatory submissions, approvals, recruitment, CRF completion and data queries; support start-up as needed.
• Ensure TMF/ISF documentation is complete and filed per regulatory requirements.
• Collaborate with study team members for project execution and site management.

Skills

Site monitoring

GCP/ICH compliance

Recruitment planning

Documentation

TMF/ISF management

Regulatory submissions

Education

Bachelor’s Degree in scientific discipline or healthcare

Job description

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 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.

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 $90,200.00 - $150,400.00. 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.