Registered Nurse - Biobehavioral Research Coordinator

Sanford Health•Fargo, ND

2d•Onsite

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, if applicable. Clinical skills may include patient assessment for adverse events and assistance with, or completion of, study-related procedures as detailed in the research protocol (e.g., 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, and the ability to collaborate with physician investigators 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 and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations, and study procedures, and reviewing inclusion/exclusion criteria to assure subject eligibility. Additionally, the position requires reviewing the study protocol and informed consent form with potential study subjects, scheduling subjects for follow-up visits to review diaries and questionnaires, ensuring appropriate specimen collection, batching, and shipping, documenting and maintaining all study-related procedures, processes, and events, documenting protocol deviations and exemptions, and recording accurate and timely data. The nurse will maintain accurate source documentation for all case report entries and input data for submission. They will use appropriate nursing assessment skills to evaluate patient condition in response to study intervention and collect data regarding patient condition for review by the physician investigator. The role also includes preparing case report forms and source documents for sponsor review, abstracting data from medical records, clinic, consultation, and referral notes for the preparation of study forms and flow sheets, and communicating effectively with subjects, the research team, the Institutional Review Board (IRB), and sponsor representatives. Occasional local travel between sites and student supervision may be required.

Requirements

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.
Enthusiasm for learning
Involvement in educating patients about the research process.

Nice To Haves

Psych or eating disorder/weight management nursing experience is preferred.

Responsibilities

Coordinating with patients
Reviewing research expectations and protocols
Data entry and lab processing
Organize complex components of clinical trials, including test ordering, procedure scheduling and insurance pre-authorization for participants, if applicable.
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.
Strictly adhere to all levels of institutional, state and federal regulations and established research protocols.
Collaborate with physician investigators to ensure safe and compliant investigational treatment or intervention and follow-up.
Attend investigator meetings and coordinate pre-study site visits.
Monitor enrollment goals and modify recruitment plan as needed.
Ensure the completion of all screening, eligibility and enrollment procedures.
Work with pharmacy to dispense study articles and provide subject education.
Clarify questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures.
Review inclusion/exclusion criteria to assure subject eligibility and review with physician investigator.
Review study protocol, informed consent form and follow-up procedures with potential study subjects.
Schedule subjects for follow-up visits to review diaries and questionnaires.
Ensure appropriate specimen collection, batching and shipping as required.
Document and maintain all study-related procedures, processes and events.
Document protocol deviations and exemptions and record accurate and timely data.
Maintain accurate source documentation for all case report entries and 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 for preparation of study forms and flow sheets.
Communicate effectively with subjects, research team, Institutional Review Board (IRB) and sponsor representatives.