CRA2 - Multi-Sponsor Department

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

Experience of independent on-site monitoring

You have successfully managed multiple clinical trial protocols across diverse investigative sites.

In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Life science degree educated or equivalent industry experience

Flexibility to travel to sites

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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.