Registered Nurse Clinical Research Coordinator

Sanford HealthFargo, ND
$28 - $44Onsite

About The Position

This is an advanced nursing position that involves clinical patient contact, research study coordination, and study data management. The role requires the ability to organize complex components of clinical trials, including test ordering, procedure scheduling, and insurance pre-authorization for participants. Clinical skills may include patient assessment for adverse events and assistance with or completion of study-related procedures such as injections, phlebotomy, or infusions, within the applicable state scope of practice. The position demands a desire and ability to strictly adhere to all levels of institutional, state, and federal regulations and established research protocols. Collaboration with physician investigators is essential to ensure safe and compliant investigational treatment or intervention and follow-up. Responsibilities include attending investigator meetings, coordinating pre-study site visits, monitoring enrollment goals, modifying recruitment plans as needed, and ensuring the completion of all screening, eligibility, and enrollment procedures. The role also involves working with pharmacy to dispense study articles, providing subject education, clarifying questions with the investigator and sponsor, reviewing inclusion/exclusion criteria, and discussing study protocols and informed consent forms with potential subjects. Scheduling follow-up visits, ensuring appropriate specimen collection, batching, and shipping, and documenting all study-related procedures, processes, and events are key duties. The role requires documenting protocol deviations and exemptions, recording accurate and timely data, maintaining accurate source documentation, and abstracting data from medical records. Effective communication with subjects, the research team, the Institutional Review Board (IRB), and sponsor representatives is crucial. Occasional local travel between sites and student supervision may be required.

Requirements

  • Active Registered Nurse
  • 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.

Nice To Haves

  • Prior research experience (preferred)
  • A collaborative, patient-centered mindset
  • 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).
  • Enthusiasm for learning required
  • Participation in educating patients, physicians, nurses and other personnel to the research process.

Responsibilities

  • Coordinate patient visits
  • Educate families on research protocols
  • Assist with lab orders, processing, and screenings
  • Organize complex components of clinical trials
  • Order tests
  • Schedule procedures
  • Obtain insurance pre-authorization for participants
  • Perform patient assessment for adverse events
  • Assist with or complete study-related procedures (e.g., injections, phlebotomy, infusions)
  • Adhere to institutional, state, and federal regulations and research protocols
  • Collaborate with physician investigators
  • Attend investigator meetings
  • Coordinate pre-study site visits
  • Monitor enrollment goals
  • Modify recruitment plans
  • Ensure completion of screening, eligibility, and enrollment procedures
  • Work with pharmacy to dispense study articles
  • Provide subject education
  • Clarify questions and concerns with the investigator and sponsor
  • Review inclusion/exclusion criteria to assure subject eligibility
  • Review study protocol, informed consent form, and follow-up procedures with potential study subjects
  • Schedule subjects for follow-up visits
  • Ensure appropriate specimen collection, batching, and shipping
  • Document and maintain all study-related procedures, processes, and events
  • Document protocol deviations and exemptions
  • Record accurate and timely data
  • Maintain accurate source documentation for all case report entries
  • Input data for submission
  • Use appropriate nursing assessment skills to evaluate patient condition in response to study intervention
  • Collect data regarding patient condition for review by the physician investigator
  • Prepare case report forms and source documents for sponsor review
  • Abstract data from medical records, clinic, consultation and referral notes
  • Communicate effectively with subjects, research team, Institutional Review Board (IRB) and sponsor representatives

Benefits

  • Opportunities for ongoing learning and professional development
  • Competitive benefits package
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