CRA 2, Oncology, IQVIA

About the Role

IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive, and track subject recruitment plans 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.
• Support the start-up phase as needed.
• Ensure copies or originals (as required) of 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.
• Support the development of project subject recruitment plans on a per-site basis, if applicable.
• Manage site financials according to executed clinical trial agreements and retrieve invoices according to local requirements, if applicable.

Requirements

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

Pay

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 job-related qualifications such as knowledge, skills, education, experience, location, and schedule (full or part-time). Incentive plans, bonuses, and other forms of compensation may be offered, along with a range of health, welfare, and other benefits.