RN Clinical Research Coordinator - Diabetes - Full Time

at  Sanford Health

JOB SUMMARY

Sanford Health is recruiting highly motivated Clinical Research Coordinators to join our type 1 diabetes team. Sanford Health has made a particular commitment to type 1 diabetes research. Our portfolio of cutting-edge trials spans the course of type 1 diabetes, from general population risk screening through immune modulation trials, both adult and pediatric. Upcoming trials will include novel agents in first-in human trials. Advanced nursing position that involves clinical patient contact, research study coordination, and study data management. Must be able to organize complex components of clinical trials, including test ordering, procedure scheduling, and insurance pre-authorization for participants, if applicable.
Clinical skills that may be required include, but not limited to: patient assessment for adverse events and assistance with, or completion of, study related procedures as detailed in the research protocol (ex: injections, phlebotomy, or infusions), within the applicable state scope of practice.
Research coordinators work closely with the Principal Investigator to manage daily operations of this portfolio. This includes study implementation, recruitment of participants, conduct of study assessments, and documentation according to standards of good clinical practices (GCP), US Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards, (IRB) and institutional policies and procedures. The research coordinator will have daily interactions with other study staff, regulatory staff, pharmacists, physicians, and other health care personnel as part of an interdisciplinary team. Opportunities and support are available for career development and advancement.
Responsibilities
Coordination of study-related responsibilities including recruitment, scheduling, obtaining informed consent, and conduct of study visits and procedures.
Phlebotomy, specimen processing, storage, and shipping.
Subject assessments and administration of medications within scope of practice.
Maintain complete source documentation and enter data into electronic data capture systems.
Prepare implementation of new studies including development of source documents.
Ensure protocol compliance and subject safety.
Participate in educational programs, process improvement activities, root cause analyses, and develop corrective and preventive action (CAPA) plans.
Activities outside of business hours or travel to regional sites may happen occasionally.
Coordinators will be expected to work towards certification by ACRP or SOCRA.

QUALIFICATIONS

Graduate from a nationally accredited nursing program preferred, including, but not limited to, Commission on Collegiate Nursing Education (CCNE), Accreditation Commission for Education in Nursing (ACEN), and National League for Nursing Commission for Nursing Education Accreditation (NLN CNEA).
Currently holds an unencumbered RN license with the State Board of Nursing where the practice of nursing is occurring and/or possess multistate licensure if in a Nurse Licensure Compact (NLC) state. Obtains and subsequently maintains required department specific competencies and certifications.

Please refer the Job description for details