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.

Competencies and work experience requirements

• Practical research experience required (in a hospital setting) with a minimum of 3 years experience in the field.
• Experience in protocol assessment and implementation.
• Good organizational skills, detail-oriented, people-oriented, self-confident, flexible and adaptable to change, with time management skills. High energy level professional.
• Knowledge of protocols and its process.
• Must be able to relate cooperatively and constructively with personnel and co-workers.
• Experience with personal computers and basic software applications, including word processing, scheduling and contact database, email, web browsing, hospital records, other database software, and office equipment.
• Requires the ability to communicate effectively in English, both verbally and in writing, and to maintain confidentiality of sensitive information.
• Maintains knowledge of, and follows, relevant departmental and Stamford Hospital policies and procedures.
• Participates in mandated Stamford Hospital / Office of Research education / training initiatives

Education requirements (Include license, registration, certification)

• Bachelor's Degree in scientific field required. RN preferred.
• Clinical research certification (such as CCRC, CCRP, CRA, IATA) preferred. If not yet certified, expected certification within 6-12 months of hire date.
• Human Research Subject Protection and Good Clinical Practice Certification
• OSHA training for handling hazardous biologic and chemical materials