Clinical Research Nurse Coordinator

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.

Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

As the Gastroenterology (GI) Clinical Research Nurse Coordinator (CRNC) you will support the divisional research portfolio by utilizing clinical nursing assessment skills to plan, provide, supervise, and document professional nursing care utilizing the nursing process for research participants in accordance with physician orders, study protocols, and established policies and procedures. Responsibilities include review of complex electronic medical records for participant eligibility, conducting ongoing participant assessments, participant education, clinical monitoring of participant safety and AEs/SAEs, and exercising professional nursing judgment while conducting research activities and closely liaising with research participants, investigators, physicians, and clinic staff.

You may supervise the activities of other licensed and unlicensed research staff. This position will perform a variety of professional nursing research activities, including IV, SQ, oral, and rectal drug administration. Additional responsibilities include consenting, conducting subject visits, specimen collection/processing/shipping, IP management, data entry, query resolution, participant payment processing, research billing review, subject and study documentation, assessing logistics for study implementation, ensuring compliance with study protocols and regulatory requirements, and supporting data analysis.

You will be integrated into a larger clinical research team and is expected to collaborate on studies that further the research mission of the GI Division while ensuring the ethical conduct of research and protection of research participants. You will report directly to the GI Division's Research Program Leader (RPL). Principal Investigators will provide scientific oversight, regulatory guidance, mentorship, and supervision in the conduct of research.

• Work requires graduation from an accredited BSN or an Associate Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelor degree in Nursing (or higher) are encouraged to enroll in an appropriate BSN program within two years of their start date but must complete the program within seven years of their start date. Must have current or compact RN licensure in the state of North Carolina.
  
  BLS required.
• Maintain compliance with required hospital and unit specific training competencies as well as an active RN status with the North Carolina Board of Nursing (NCBON).
• Twelve months of appropriate clinical nursing experience is required.

• Previous clinical research experience

Clinical responsibilities:

• Ambulatory Medication Administration
• Adult Medication
• Pediatric Medication
• OR Medication
• Peripheral IV Insertion and Maintenance
• Alaris Pump Set up and Use
• Draw blood from arterial lines
• Basic Dysrhythmia Review Vasoactive Drips
• Other:
  The Gastroenterology (GI) Clinical Research Nurse Coordinator (CRNC) will support the divisional research portfolio by utilizing clinical nursing assessment skills to plan, provide, supervise, and document professional nursing care utilizing the nursing process for research participants in accordance with physician orders, study protocols, and established policies and procedures. This position will perform a variety of professional nursing research activities, including IV, SQ, oral, and rectal drug administration.

• Onsite. The work is performed on-site or at a designated assignment location.

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). May train or oversee others. Knowledgeable in regulatory and institutional policies and processes. Applies…