Clinical Research Study Coordinator (Registered Nurse)

Company: Arkansas Heart Hospital

Updated: 8/21/2012


This position is responsible for coordinating and participating in clinical research studies conducted by AHH investigators. Performs a variety of patient/subject-related care and administrative duties to support activities that meet objectives of assigned research protocol(s). - Provides subject screening, care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principals. - Confers with subject and physician to explain purpose of study. - Explains diagnostic procedures and method of treatment to answer subject and family concerns. Obtains written consent for subject to participate in a study prior to initiation of any protocol procedures. - Coordinates research activities, including screening, consenting and scheduling tests or exams for study subjects. - Collects pertinent information and data from subject charts and records, subject interviews and other sources. - Completes case report forms (CRFs) in accordance with research protocol guidelines. - Maintains accurate records of the receipt, inventory and dispensation of study drugs and/or devices and materials. - Reviews CRFs, source documentation and study files with representative(s) from sponsor or from the Food and Drug Administration (FDA). Makes necessary corrections to CRFs and submits requested documentation in a timely manner. - Maintains research regulatory documents and patient documents for the department and individual study sponsors. - Collects and processes adverse events. - Complies with standard operating procedures of AHH, sponsor and institutional review board (IRB). - Compiles and submits reports, documents and correspondence as necessary to the IRB or sponsor. - Assists with study initiation visits and monitoring visits by research sponsors. - Provides training and direction to new personnel on protocol procedures. - Maintains current knowledge of regulations governing clinical research. - Initiates and participates in problem-solving discussions within a functional teamwork concept. - Maintains all research patient records with strictest confidentiality. - Attends research meetings and conferences as required. QUALIFICATIONS: - Education: Graduate of an accredited nursing program required (effective March 28, 2012). - Licensure/Certification: Registered Nurse with current state licensure or licensure from a state within the Nursing Compact (effective March 28, 2012). BLS certification required within 30 days of placement in position (effective March 28, 2012). CCRC and/or CCRP preferred, or must be obtained within two and one-half (21/2) years of employment in this position. - Experience: Minimum of one year of registered nursing experience in a medical or research environment required to allow familiarity with basic medical and research terminology and procedures (effective March 28, 2012); cardiology/cardiovascular experience preferred. PLEASE GO TO TO APPLY