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, 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.

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.

Qualifications

Essential functions include performing site monitoring visits, administering study training, evaluating study site practices, managing study progress, and collaborating with study team members.

Skills

Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, ability to administer study training, evaluate study site practices, manage study progress, and collaborate with study team members are essential.

Benefits

The posting does not specify any benefits.

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 a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).

Schedule

The posting does not specify the schedule.