Clinical Trials Coord-Unlic.

Major accountabilities/Critical responsibilities

• Review institutional review board approved protocol and protocol documents prior to study activation and patient enrollment.
• Review patient charts, database records, and other sources to screen and identify potential subjects for inclusion in a study.
• Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.
• Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records and coordinating the collection and shipments of specimens as required by protocol.
• Communicates study objectives and procedures to all relevant hospital units involved with the study, including the establishment of good rapport with the Principal Investigator and providing him/her with the required assistance.
• Communicates with the Sponsor or its representatives, schedules and facilitates study Monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor's representatives.
• Educate physicians, nurses, and ancillary staff regarding investigational product, trial activities, and requirements.
• Meet with potential subjects and their families to explain trial and treatment plan, and provide emotional and educational support.
• Interacts with patients and families to ensure compliance with the protocol.
• Obtain written informed consent for subject to participate in trial prior to performing any study-related procedures.
• Maintains drug supplies as directed by the study protocol.
• Assists the Director and Manager with protocol evaluation and feasibility.
• Responsible for speedy and adequate patient enrollment in all assigned studies.
• Submits new protocols to IRB and verifies that the proper document was received. In addition, submits amendments of protocols to IRB and verifies that the required corrections were inserted following the established procedures.
• Trains less experienced team members.
• Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows Stamford Hospital’s Standard Operating Procedures, AAHRPP, HIPPA, and FDA guidelines for clinical research, keeps updated with those procedures and/or guidelines, and complies with finance compliance policies and procedures.