Ensures compliance of research program and associated research studies. Coordinates the compliant implementation and conduct of human subject research projects by utilizing the nursing process, of medium to high workload and medium to high complexity. Assists with research study design and protocol development.
Coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements, timely completion and communication of regulatory documents, the development of data capture and monitoring plans, reporting of Serious Adverse Events as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP timelines.
Serves as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
Utilizes the nursing process as a basis for patient care.
Assesses research subject and completes nursing assessment, documenting findings in research subject records then, notifies physician of abnormal findings.
Establishes a care plan in collaboration with the research subject, family and research team to coordinate ongoing care.
Identifies discharge needs and facilitates discharge planning as appropriate.
Performs telephone triage.
Performs nursing procedures and treatments as directed by physician or LIP in the treatment and management of patient care.
Evaluates, initiates and maintains standards of care consistent with CCHS policies and procedures.
Assists with specialized patient care equipment as required by the clinical research protocol.
Administers medications and treatments as ordered by a physician or LIP.
Directs, coordinates and participates in the evaluation and supervision of nursing care provided to research subjects; establishing patient care priorities and delegating nursing activities according to the patient needs and staff qualifications and capabilities.
Participates in education, research and performance improvement activities.
Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols.
Assists with preparation for audits and response to audits.
Maintains professional relationships, including frequent and open effective communication with internal and external constituents.
Assists with the development of training and educational material for assigned research protocols. Provides and documents education as needed.
Conducts and documents the informed consent process.
Assists with research study design, development of research protocol and research project budget development.
Other duties as assigned.
Graduate from an accredited school of professional nursing.
Bachelor of Science in Nursing preferred.
Within 90 days of hire, must successfully complete certification in Human Subjects Research as required by the Responsible Conduct of Research guidelines adopted by Cleveland Clinic.
Continually demonstrates competency with defined requirements for the position as established by Cleveland Clinic.
Current state licensure as Registered Nurse (RN).
Proof of Basic Life Support (BLS) certification must be presented upon hire.
COMPLEXITY OF WORK:
Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision.
Must be able to work in a stressful environment and take appropriate action.
Demonstrates basic computer proficiency.
Must have strong organizational, communication and interpersonal skills.
Must be self-directed with demonstrated ability to work independently yet establish cooperative relationships with colleagues.
Meets clinical competency requirements.
Maintains current knowledge in specialty area.
Participates in process improvement activities.
Minimum five years clinical experience, clinical research experience preferred.
Requires full range of body motion, manual and finger dexterity, and eye-hand coordination.
Requires standing and walking for extended periods of time.
Requires corrected vision and hearing to normal range.
Requires working under stressful conditions and irregular hours.
Exposure to communicable diseases and/or body fluids.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. Physical Demand requirements are in excess of those for Light Work.
PERSONAL PROTECTIVE EQUIPMENT:
Follows standard precautions using personal protective equipment as required.