Clinical Research Study Coordinator (Registered Nurse)

Description:

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.


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