UNIV - Registered Nurse III - Department of Medicine: Division of Cardiology

Job Description Summary

Primary RN research coordinator for Phase I/II/III drug trials and early phase medical devices within all subcategories of Cardiology. Provides leadership and direction to professional and paraprofessional nursing personnel in direct patient care, patient and student education and counseling, coordination of clinical and research services for patients and their families.

35% - Act as Primary Coordinator for Phase I/II drug trials and early phase medical device trials. Coordinate and/or deliver nursing care (labs, medications, questionnaires, nursing physical assessment and vital signs, patient and family education) and serve as the primary liaison between the patient and the PI/study coordinator regarding implementation of study protocol through duration of study activities. Serve as primary liaison with Sponsor/CRO for studies in which RN serves as primary nurse coordinator.

Coordinate follow-up care according to study protocol. Coordinate outpatient clinic visits during immediate and long-term follow-up.

25% - Screen and identify patient candidates that meet specific criteria for eligibility and study enrollment. Provide essential information/education to potential candidates regarding all aspects of clinical trials. Enroll study participants by obtaining informed consent and randomization. Primary liaison between the patient and the Principal Investigator (PI) and Co Investigator regarding consent and inclusion/exclusion documentation for patient enrollment. Assist the hospital nursing and medical staff with the study protocol to facilitate a smooth flow for the patient.

Coordinate the scheduling of appointments with the study protocol timelines.

15% - Maintain up-to-date training for assigned projects. Review, evaluate and report to (PI) and Nurse Manager monthly, as to study status. Assist with preparation for Data Safety Monitoring Board meetings. Collaborate with all members of the research team in developing and implementing strategies for effective management of research study.

10% - Coordinate proper data management according to protocol requirements and in compliance with Good Clinical Practice. Maintain and update the secure, confidential, password protected computer database created for data storage, data management, case report forms, and subject randomization for the current research investigation. Maintain and preserve confidentiality for other research files and notebooks with patient information. Working knowledge of Microsoft Office, Excel, and PowerPoint is required.

5% - Assists with the preparation and submission of necessary documents to the MUSC Office of Research Programs to ensure compliance with IRB and FDA requirements. Coordinate/perform the reporting and communications with the IRB and the study sponsor (ADA) as relevant to research protocols, study implementation, adverse events (AEs), ongoing study updates, and other activities necessary for exceptional performance from inception to close.

5% - Continuously examine and evaluate the effects of the research regimen on study subjects and contribute to the advancement of services provided to same in promoting health education and communication. Ensure compliance/adherence to the Sponsor and MUSC’s policies, requirements, legal contracts and HIPPA regulations.

5% - Other projects assigned by the nurse manager.

Minimum Requirements:

Graduation from an accredited school of nursing and two years of related nursing experience. Licensed as a registered nurse by the State Board of Nursing for South Carolina. Some positions require a valid driver’s license. Also, some positions require certification in Basic Life Support and/or Basic/Advanced Cardiac Life Support.

Ability to perform job functions in an upright position. (Continuous) Ability to perform job functions in a seated position. (Infrequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to climb stairs. (Infrequent) Ability to climb ladders. (Infrequent) Ability to work indoors. (Continuous) Ability to work from elevated areas. (Infrequent) Ability to work in…