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Clinical Research Nurse/Cmed

2 months ago

Mt Pleasant, United States Central Michigan University Full time

Clinical Research Nurse/Cmed Position Number: S-3209 Type of Recruitment: External Position Summary: This position is comprised of both clinical responsibilities and regulatory responsibilities. Clinical responsibilities may include assisting with developing and implementing the activities of a clinical research trial which consists of selection of patients, treatment procedures, drawing blood, performing EKGs, recording adverse events, withdrawals, ethical/legal practices, monitoring and audit preparation. This position may be expected to act as the primary contact with the sponsor's study monitoring individual(s), be a resource for developing operational plans, become an expert regarding the study plan, and maintain awareness of all ongoing activities, ensuring proper handling of all paperwork. Depending upon the type and complexity of a given trial, these roles and responsibilities may be shared with or assigned to other research staff at the discretion of the Director of Clinical Research or Principal Investigator (Pl). Regulatory responsibilities include understanding of compliance with federal, state and local laws as they relate to the performance of human patient's research, as well as preparation and maintenance of all regulatory documentation for assigned studies. This position may be responsible for presenting the study to the Institutional Review Board (IRB) and/or other departments. It is the responsibility of the position to schedule and conduct study specific training for any additional staff, within the research department as well as ancillary departments. Required Qualifications: Graduation from an accredited school of nursing. Current registration with the State of Michigan Board of Nursing as a Registered Nurse (RN). Certificate of completion for CITI training or willingness to obtain certification. One year nursing experience related to the duties of the position. Strong interpersonal and communication skills required. Ability to analyze and interpret data and maintain confidentiality required. Preferred Qualifications: Bachelor of Science in Nursing degree. BLS certification. Experience conducting single/multicenter clinical trials, human subject research or similar activities. Duties & Responsibilities: Acts as a liaison between hospital physicians and principal investigator (PI). Professionally interacts with physicians, hospital committees, etc. Works collaboratively with investigator, sub-investigators, referring physicians, patients and their families, other clinical research coordinators, vendors, research organizations, and hospital staff. Continually networks at sponsored research events as a representative for CMU College of Medicine. Develops and collaborates with research sponsors for upcoming research studies. Acquires and maintains thorough knowledge of current research procedures, guidelines, federal regulations, and specific protocol requirements. Recruits consent study patients and establishes a patient/coordinator relationship. The CR-RN must be attentive to patient's specific needs and discuss them with the Pl. Coordinates all aspects of research study exercises. Carries out assigned work as required for specific duties related to study preparation, execution, and post-study documentation. Performs study-specific duties, including but not limited to, completion of case report forms, coordinating/tracking patient visits, and receipts and processing of various reports generated by sponsor, site liaison for sponsor/monitors, and query resolution. Assesses patients for consenting into clinical trials based on inclusion/exclusion criteria. Executes and conducts study visits. Prepares documentation as required by the study sponsor and/or the Pl. Trains study patients under direction of the Pl. Conducts the following: Lab set-up a