CRA 2, Oncology, IQVIA

IQVIA; Parsippany-Troy Hills (NJ); On-site; USD 87,000 - 145,000; Full time

Job summary

IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience to join our clinical operations team in the United States.

You will perform site monitoring visits, manage recruitment plans, ensure GCP compliance, and collaborate with sites and study teams to maintain TMF/ISF and regulatory submissions.

Qualifications

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

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with GCP/ICH guidelines.
• 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, recruitment/enrollment, CRF completion and submission, and data query generation and resolution; may support start-up phase.
• Ensure copies/originals site documents are available for filing in the Trial Master File and verify ISF is maintained per GCP and local requirements.
• Create and maintain documentation regarding site management, monitoring visit findings and action plans via visit reports, follow-up letters and other docs.
• Collaborate with study team members for project execution support; may be accountable for site recruitment plans and site financial management when applicable.

Skills

GCP knowledge

ICH guidelines

On-site monitoring

Site management

Regulatory submissions

Education

Bachelor’s Degree in science

Tools

TMF / ISF management

Job description

Durham, North Carolina, United States of America

Columbus, Ohio, United States of America

Collegeville, Pennsylvania, United States of America

Boston, Massachusetts, United States of America

Chicago, Illinois, United States of America

San Antonio, TX, United States of America

Kansas City, MO, United States of America

Fort Worth, TX, United States of America

Wayne, PA, United States of America

Indianapolis, Indiana, United States of America

Wilmington, DE, United States of America

Houston, Texas, United States of America

Parsippany, New Jersey, United States of America

Philadelphia, PA, United States of America

Dallas, Texas, United States of America

Orchard Park, New York, United States of America

Full time

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. 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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