Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
Conducts on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
Serves as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues; liaises with appropriate study team members as needed.
Communicates through verbal and written communication with site investigator and project team regarding overall site performance, trends, deficiencies, and concerns.
Supports study start‑up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters.
Performs study‑related training.
Manages the development and maintenance of study documents, processes and systems as assigned.