PRIMARY FUNCTION:

Under general supervision of the Principal Investigator and Vice Chair for Research/Director- Vickie and Jack Farber Vision Research Center, manages complex clinical trials in accordance with FDA GCP guidelines.

• Responsible for overall coordination of site-specific clinical trial activities.
• Responsible for maintaining ongoing communication with the study team, sponsor, CROs, other relevant entities at Wills, (e.g. IRB, Director of Sponsored Projects, finance) and study subcontractors, including scheduling routine study team meetings.
• Manages and participates in all aspects of sponsored clinical trial preparation, start up and implementation, including obtaining informed patient consents, patient screenings for eligibility, enrolling/monitoring study patients in an outpatient setting, and ensuring protocol compliance.
• Reviews protocols with PI and makes all necessary preparations for the study.
• Schedules subject visits and any necessary testing.
• Monitor subjects per protocol requirements and ensure adherence to all protocol requirements.
• Assists with preparation and filing of Institutional Review Board (IRB) applications and responses to inquiries.
• Organizes and maintains complete and accurate study documentation, including regulatory binders, and all documentation required by the sponsor including source documentation, case report forms, and research charts.
• Responsible for all documenting, adverse events reporting, and maintenance of regulatory files with accuracy and timeliness.
• Collects, reviews and reports study data to the sponsor, completes case report forms and submits to EDC, resolves data queries, processes and ships study specimens including blood and tissue samples.
• Documents all communications between patients, investigators, monitors and sponsor related to specific study and files with CRF, subject source document and regulatory binder.
• Works closely with the Principal Investigator, Vice Chair for Research and study team to identify problems relating to study conduct (e.g., recruitment, follow-up and staffing) and develop solutions. Implement approved changes to procedures as needed and monitor results.
• Schedules, assists in preparing for and participates in on-site visits with the sponsor, including initiation, monitoring, audit and close-out visits.
• Schedules and participates in study team meetings and ongoing protocol training/compliance meetings.
• Ensures patient safety, protocol compliance and data quality.
• Serves as a liaison between the patient, investigator, IRB and study sponsor in an effective and timely manner.
• Closes the study with the sponsor and stores study records appropriately.
• Applies knowledge of regulatory processes including Institutional Review Board (IRB), Good Clinical Practice (GCP) to all aspects of study conduct.
• Adheres to all hospital, FDA and GCP guidelines.