Clinical Research Coordinator

Job Description

Participate and coordinate in clinical research studies conducted by supervising physician. Perform a variety of administrative duties to assist in the conduct of research trials. Supervises data manager and interns. Responsible for study initiation, subject recruitment, follow-up, data management, detailed record keeping and regulatory compliance, report writing, and correspondence with investigators, sponsors / CROs, IRBs, and regulatory authorities. Responsible for the new submission of protocols with subsequent amendments. Some participation in protocol writing. Educate research subjects, physicians, nurses, and ancillary staff on available research studies, study treatment / required activities, and use / side effects of investigational study drug. Responsible for initial and continuing education for Good Clinical Practice compliance.

Responsibilities

• Review institutional review board approved protocol and protocol documents prior to study activation and patient enrollment.
• Coordinate Study feasibility and initiation.
• 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.
• Collect pertinent information and data from study subject interviews, charts, study electronic devices and other sources.
• Meet with study sponsor and regulatory representatives to review and discuss conduct of the trial.
• 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.
• Coordinate research activities, including schedule appointments, laboratory tests, radiology and cardiology testing.
• Assists with maintaining accurate records of the receipt, inventory, and dispensation of study drug and materials.
• Assists the Director and Manager with protocol evaluation and feasibility.
• Responsible for speedy and adequate patient enrollment in all assigned studies and reflective of meeting department goals as proportionate to studies assigned.
• Compile and submit reports, documents, and correspondence to trial sponsor, institutional review board, and regulatory agencies.
• Oversees or 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.
• Complete protocol required case report forms accurately, completely, and in a timely manner in Electronic Data Capture system or paper format.
• Prepare or oversee the preparation of biologic specimens for shipment to study reference laboratory.
• 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.
• Responsible for the interdepartmental technical logistics for Device and Facility Use studies.

Qualifications