Teams at DM Clinical Research

Coordinates clinical research studies at investigative sites, ensuring protocol compliance, accurate documentation, timely data entry, query resolution, patient consent, safety-event reporting, laboratory procedures, participant enrollment, and communication with investigators, sponsors, CROs, and research teams. Requires knowledge of FDA regulations, ICH-GCP guidelines, study protocols, and research documentation. The role includes occasional travel to out-of-town Investigator Meetings.

Manages clinical research studies at investigative sites from first patient visit through closeout. Ensures protocol, FDA, ICH-GCP, SOP, documentation, safety-reporting, consent, data-quality, enrollment, and compliance requirements are met. Trains site teams, prepares for sponsor and CRO visits, maintains essential trial documents, supports patient visits and informed consent, coordinates cross-functional teams, and helps achieve enrollment and operational goals.

Collects and reviews clinical research data to identify inconsistencies, quality issues, and trends affecting study outcomes. Coordinates with regulatory, clinical data, and research site teams; documents action items from site visits, audits, and monitoring; escalates unresolved issues; and maintains query repositories. Ensures compliance with ALCOA+, GDP, GCP, and FDA requirements, reviews clinical source documents, performs root cause analysis, and completes administrative and priority tasks within deadlines.