Clinical Nurse Coordinator
The [company name] is a state-of-the art research facility with over fifty inpatient beds. The unit is a satellite facility of the Groton/New London Pfizer campuses, and is designed to provide comprehensive clinical care and research using cutting edge technology. The CRU houses its own sophisticated laboratories, pharmacy and personalized electronic data capturing and reporting system. The CRU conducts Phase I- Phase III clinical research studies in many different therapeutic areas including: Alzheimer's, Diabetes, Schizophrenia, Hemophilia, Rheumatoid Arthritis, Erythromyalgia and Lupus. The responsibilities of the clinical nurse coordinator: Assures trials are in accordance with regulatory requirements/guidelines (scientific, medical, and ethical principles). Coordinates day to day execution of assigned protocols from recruitment through last subject, last visit. Leads and oversees a clinic team (e.g., nurses, techs, sample processers, phone screeners, clinic screeners) to ensure subject safety, accurate interpretation of medical tests and execution of research protocols (e.g., ICD development, recruitment plans, source document creation, specimen collection activities). Recruits subjects; schedules and tracks potential subjects; maintains electronic records; follows-up referral appointments/treatments as directed. Develops customized recruitment strategies, tools and documents to support subject recruitment (e.g., patient trials), as appropriate. Performs informed consent discussions with subjects; creates, maintains and administers informational tools to assist volunteers with study comprehension and compliance. Participates in QC of study set up in the electronic data capture system for protocols according to protocol requirements, CRU SOP's, and standardized processes, as appropriate. Assists in study design as it relates to feasibility, implementation, and reporting of clinical trials. Reviews and provides input on protocols; interprets protocol detail and organizes study activities including the creation of study. Maintains accuracy, accessibility and confidentiality of all volunteer records and reports. Ensures that all subject records are consistently maintained in a state of inspection readiness; performs ongoing quality reviews of the data to achieve audit-readiness and to meet strict archiving timelines. Leads and supports ICD development, informed consent session and subject orientation sessions.
- Monitors cardiac function/status through ECG and telemetry, and provides emergency "Code Blue" interventions, as appropriate.
- Mentors, orients and trains new CRU clinical colleagues and contractors (e.g., telemetry, pulmonary function, EEG requirements, ACLS/BLS, ECG, vital signs).
- Responsible for the collection of biologic specimens and clinical measurements (phlebotomy, blood pressure, pulse oximetry, heart rate, respirations, telemetry, ECG, and cognitive exams).
- Assures subject safety, including assessment of physiologic response to drug administration (adverse event reporting) as well as administers medications by various routes (e.g., PO, IV, IM, SC, transdermal, and pulmonary).
- Evaluates adverse events and intervenes as appropriate; maintains accuracy, accessibility, and confidentiality in subject records and reports.
- Nominated liaison and trainer for Mortara ECG and telemetry monitoring systems.