About This Role
This role involves performing site monitoring visits for clinical research studies, ensuring compliance with regulatory requirements, and managing the progress of assigned studies. It suits a candidate with experience in on-site monitoring of interventional studies who can establish effective working relationships with coworkers and clients.
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
- May support the 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
Requirements
- At least 2 years of on-site monitoring experience of interventional studies
- Degree in a scientific discipline or health care, or equivalent industry experience
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Ability to establish and maintain effective working relationships with coworkers and clients
- Full UK right to work required; this position is not eligible for visa sponsorship
About the Company
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. The company creates intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
