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
* 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
Qualifications
* Requires at least 1 year of independent on-site monitoring experience of interventional studies in the UK
* Good knowledge and skill in applying applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
* Good therapeutic and protocol knowledge as provided in company training
* Ability to establish and maintain effective working relationships with coworkers, managers, and clients
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