Clinical Research Nurse Coordinator II

Medstar Research Institute
Washington, DC
Jun 28, 2022
Jul 07, 2022
Full Time
Full TimeResearch-MCRC110 Irving St NWResearchDay/Night/Weekend shifts with on-call duties1.00 Job Summary Under the direction of the Principal Investigator (PI), with minimal supervision and within the scope of nursing practice, the proficient Clinical Research Nurse Coordinator II (CRNC II) assesses, plans, implements, and evaluates the nursing care of potential research participants from pre-screening through study exit. The CRNC II 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. Perceives and understands study participant situations in a holistic manner leading to improved decision making. Understands from experience what to expect in certain situations and how to modify plans. The CRNC II is responsible for the implementation of their assigned portfolio of studies, will perform diverse administrative duties requiring a high level of knowledge of study specific protocols, analysis and sound judgment. The CRNC II seeks knowledge and competency that reflects current clinical research nursing practice and promotes futuristic thinking. Minimum Qualifications Education/Training Bachelor of Science with active nursing license required Experience 1 year of clinical nursing experience. 2 years of research experience. License/Certification/Registration Registered Nurse license in the state in which you are practicing, with the ability to get reciprocity if needed. Basic Life Support (BLS), CPR required. Knowledge, Skills & Abilities Verbal and written communication skills. Basic computer skills preferred. Primary Duties and Responsibilities 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 participant care, including clinical assessment to identify needs and problems experienced by participants and their caregivers. Facilitates feasibility assessment, site qualification, study initiation and monitoring visits; works effectively with multidisciplinary, ancillary and inter-professional research teams; possesses a clear understanding of scientific center goals and the importance of serving our customers. Participates in all audits and inspections and maintains audit-ready status. Assists and/or 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). Oversees the informed consent process according to MHRI consent policies and procedures and Good Clinical Practices (GCPs). Reviews consent form with research participants and ensures that the participant and family understand plan of care and health status implications. Act as an advocate in meeting participant and family needs related to research protocol. Collects comprehensive 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 (eg, OnCore Clinical Trial Management System [CTMS]); enters data into various auditable databases or electronic data capture systems (eg, REDCap). Uses evidence-based nursing expertise to develop a plan that uses strategies and alternatives within parameters of the research protocol, identifies expected measurable outcomes, and analyzes assessment data to determine actual or potential diagnoses, problems, and issues within the parameters of the research protocol. Implements the identified healthcare and research plans and practices ethically and in a manner that is congruent with inclusion principles. Uses nursing skills, knowledge and tools to complete assessments (eg interview, observation, and physical examination (if applicable) of subjects 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 article; 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 (eg, 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 multidisciplinary quality and service improvement teams as appropriate. Coordinates meetings, serves on committees and represents the department and hospital/facility in community outreach efforts as appropriate. Performs other duties as assigned.

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