GENERAL SUMMARY OF POSITION

Under the direction of the Principal Investigator (PI) and within the scope of nursing practice, the competent Clinical Research Nurse Coordinator I (CRNC I) with moderate supervision, assesses, plans and implements and evaluates the nursing care of potential research participants from pre-screening through study exit. Position functions under the direction of an experienced nurse to provide patient care relevant to the protocol, while using professional judgment and sound decision making. The CRNC I demonstrates professional accountability and responsibility for nursing practice, and coordinates care delivery with the principal investigator and other members of the clinical research teams and family. Gains perspective from planning own actions based on conscious, abstract, and analytical thinking, and helps to achieve greater efficiency and organization. The CRNC I is responsible for the implementation of their assigned portfolio of studies, which may include but not limited to IRB applications and related forms, data collection forms, patient screening and enrollment, verification of investigative procedures to accomplish research goals, and preparation of reports.

EDUCATION

• Associate’s degree in Nursing required and
• Bachelor’s degree of Science in Nursing preferred

EXPERIENCE

• 1-2 years Experience of clinical practice or minimum 1 year of research experience. required

KNOWLEDGE, SKILLS, AND ABILITIES

• Verbal and written communication skills.
• Basic computer skills preferred.
  This position has a hiring range of $87,318 - $157,289

• Contributes to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards, and safety standards. Complies with governmental and accreditation regulations.
• Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.
• Performs skills and duties that are within the scope of nursing practice, with the ability to write orders with physician co-signature in the patient medical record (MedConnect). Incorporates the nursing process into holistic research participant care, including clinical assessment to identify needs and problems experienced by participants and their caregivers.
• Facilitates site qualification, study initiation and monitoring visits; works effectively with multidisciplinary, ancillary and inter-professional research teams; possesses a basic understanding of scientific center goals and the importance of serving our customers. Participates in all audits and inspections and maintains the site in an audit-ready status.
• Assists and/or is responsible for the Institutional Review Board (IRB) submissions and other related regulatory forms; coordinates essential regulatory documents and submits timely and accurate regulatory documents to the Sponsor, as applicable.
• Pre-screens potential research participants to determine initial eligibility and interest in a research study and adheres to guidelines to protect Protected Health Information (PHI).
• Conducts the research participant informed consent process according to MHRI consent policies and procedures and Good Clinical Practice. Ensures that the participant and family understand plan of care and health status implications, and act as an advocate in meeting participant and family needs related to research protocol.
• Collects data pertinent to the research protocol requirements and the research participant’s health and/or situation. Assists the clinician/investigator in ensuring adequate source documentation and data-collection that validate the integrity of the clinical trial/research study. Documents participant encounters are updated as appropriate and within one (1) business day in a recognized electronic system/database (e.g., OnCore Clinical Trial Management System CTMS); enters data into various auditable databases or electronic data capture systems (e.g., REDCap).
• Implements the identified healthcare and research plans, communicates effectively to all study personnel, employs strategies to promote health and a safe environment, and practices ethically and in a manner that is congruent with inclusion principles.
• Completes study required assessments using interview, observation, and physical examination (as appropriate) of participants consented for participation in research.
• Administers or provides oversight of administration of investigational product and other treatment agents or study interventions, as appropriate.
• Maintains current Occupational Safety and Health Administration (OSHA) training regarding bloodborne pathogens; maintains International Air and Transportation Association (IATA) training for routine packaging, labeling and transporting of biological materials to ensure proper collection, processing and shipment of biospecimens, as needed.
• Receives and inventories test articles (study device or drug); works with research pharmacist, as applicable; stores test articles according to Food and Drug Administration (FDA) regulations and Sponsor requirements; with oversight, administers test articles; retrieves test articles and calculates research participant compliance, as applicable; reconciles accountability log, and completes research participant record.
• Understands and complies with rules for billing Medicare, Medicaid and third-party payors for services, drugs, devices, tests and procedures rendered in the clinical research context; responsible for following the billing matrix/billing plan generated by administration for research participants enrolled in clinical studies; ensures research participant stipend information is submitted.
• Optimizes the safety of research participants by answering participant questions regarding specific dose and side effects regarding investigational product and assess adverse events. Informs investigator of adverse events and documents seriousness, causality and intervention; acts on investigator’s recommendation for adverse event intervention (e.g., stop test article, call research participant, re-test, treat); maintains follow-up to determine resolution of adverse event. Report all serious ADE’s to the principal investigator, sponsor, primary care physician (as applicable), and IRB as outlined in the protocol.
• Coordinates study close-out activities. Oversees the return, disposal and/or destruction of unused supplies per Sponsor requirements; reconciles test article accountability; documents research participants who are lost to follow-up or who withdraw consent; assists in the preparation for a potential routine pre-market approval (PMA) FDA inspection as applicable.
• Must comply with international, federal, state, Sponsor and MHRI policies; must possess basic understanding of the ethical treatment of research participants and of Good Clinical Practices (GCPs), aspects of human protection and safety in the conduct of clinical research (21 CFR 50 Protection of Human Subjects, 21 CFR 54 Financial Disclosure, 21 C FR 56 Institutional Review Boards). Maintains required MHRI trainings including but not limited to Collaborative Intuitional Training Initiative (CITI), Conflict of Interest (COI), and annual MedStar Health mandatories.
• Participates in multi-disciplinary quality and service improvement teams.