Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
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 to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and / or line manager.
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.
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.
May provide assistance to less experienced clinical staff.