Principal HealthCare Professionals perform clinical research-related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Principal Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. This position operates as a Clinical Research Nurse (RN).

Examples of Duties Performed

  • Obtain study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
  • Oversee and provide informal leadership to the team members, including managing day-to-day priorities, evaluating and redistributing workloads on a temporary basis, and mentoring staff
  • Coordinate and administer patient care in compliance with protocol requirements
  • Disburse investigation drug and provide patient education regarding administration
  • Oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Independently review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document and report all findings to physician and care team
  • Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
  • Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
  • Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
  • Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
  • Assist with and oversee the day to day operations of clinical trials and studies
  • Adhere to research regulatory standards
  • Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
  • Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
  • Ensure that the necessary supplies and equipment for studies are in stock and in working order
  • Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
  • Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
  • Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
  • Act as a Primary Coordinator on multiple trials/studies
  • Assist and train junior team members
  • Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
  • Assist with identifying issues related to operational efficiency and shares results with leadership
  • Collect, code, and analyze data obtained from research in an accurate and timely manner
  • Serve as a resource and participate in study initiation and close out duties

This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Minimum Qualifications

  • Bachelor of Science in Nursing (BSN) degree
    • An Associate Degree in Nursing (ADN) degree and two (2) additional years of experience will substitute for the BSN degree
  • Current licensure as a registered nurse
  • Three (3) years clinical research or related experience

Preferred Qualifications

  • Bachelor’s degree in science or health related field
  • Four (4) years of clinical research or related experience
  • Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
  • Experience with COMIRB

 

Competencies, Knowledge, Skills, and Abilities

  • Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
  • Ability to communicate effectively, both in writing and orally
  • Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
  • Outstanding customer service skills
  • Demonstrated commitment and leadership ability to advance diversity and inclusion
  • Knowledge of basic human anatomy, physiology medical terminology
  • Ability to interpret and master complex research protocol information
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