Registered Nurse - Clinical Research Coordinator-Clinical Trials Unit Section

JOB DESCRIPTION

The role of the Registered Nurse-Clinical Research Coordinator (RN-CRC) is accountable for managing and/or participating in all phases of the research process. The RN-CRC supports professional nursing practice across practice settings and across the continuum of care to meet the needs of the research participant and family, as appropriate. The RN-CRC understands and advocates for human subject rights, and coordinates participant/family education in the clinical research setting. Work is primarily self-directed with guidance from the staff physicians and/or principal investigators. The Registered Nurse-Clinical Research Coordinator participates in organizing and monitoring protocols, plans for and participates in staff education in areas where protocols will be carried out. The RN-CRC assesses research participants, investigates abnormal patterns of adverse events and laboratory results, and reports appropriately. The RN-CRC interacts with other departments to develop systems/procedures for coordinating phases of study protocols that comply with local and international regulatory laws, and institutional guidelines for study data collection, storage, retrieval, and research participant medical tests investigational drugs/devices and procedures.

RESPONSIBILITIES

Collects Patient Health Data

• Collects and reviews health data in a comprehensive and systematic format by assessing, observing, and evaluating an individual patient/family based on established practice guidelines and protocols.
• Assesses patient/family educational needs, readiness to learn, barriers to learning, appropriate to the age of the patient, utilizing appropriate resources.
• Utilizes communication techniques appropriate to the age and abilities of the patient/family as appropriate.
• Interprets and focuses the assessment data collected from the patient/family interaction and other available sources to reflect the patients status.
• Thoroughly documents relevant data in a retrievable form.
  
  

• Establishes a plan that provides for continuity of care utilizing current nursing practice guidelines.
• Develops a plan with the patient, family and health team members, when appropriate.
• Documents the plan of care.
  
  

• Implements the plan of care in collaboration with other members of the health care team.
• Conducts patient and family teaching consistently.
• Performs treatments and procedures according to research protocol guidelines.
• Maintains a safe, clean and organized environment for the patient/family, visitors and staff.
• Applies the principles of asepsis and infection control to patient areas.
• Documents actions taken during the patient interaction, patient outcomes and plans for future interventions.
  
  

• Provides a systematic, ongoing and criterion-based evaluation.
• Involves the patient, family and health care team members in the evaluation process.
• Reassesses and modifies the plan based on patient outcomes as appropriate.
• Documents the patients response to interventions.
  
  

• Acts as a patient advocate for research participants, listens to their care concerns and research related issues.
• Provides care with respect for the patient enrolled in a clinical research study and their familys privacy, dignity, personal preference and culture.
  
  

• Reviews protocol and drafts budget justification. Estimates nursing coordinator time based on previous experience in patient evaluation. Works with Research Administrative Services staff (finance specialist) and presents organized, detailed draft budgets.
• Determines feasibility of study based on staff and facilities available, while maintaining a concern for research participant safety and comfort.
• Interfaces with principal investigator/sponsor/research administrator in a professional manner, acquiring necessary paperwork and signatures to initiate protocol. Active engagement in budget development and revisions. Drafts consent form from principal investigator/sponsor sample using SSMC consent form template.
• Develops and conducts training for staff responsible for non-nursing protocol procedures and tasks.
• Attends and contributes to investigator/study coordinator meetings upon study initiation and periodically throughout protocol life, as required by protocol principal investigator/sponsor.
  
  

• Develops effective screening tools and teaching brochures/methods to be used when determining patient eligibility.
• Assesses time allowance for adequate performance of research participant visits and structures own schedule accordingly.
• Arranges for appropriate publicity using SSMC-approved procedures based on knowledge and type of research participant recruitment.
• Communicates knowledgeably about drug/device side effects, complications, and known efficacy.
  
  

• Reports serious, unexpected adverse events to IRB and principal investigator/sponsor.
• Follows up on adverse event reporting with a clear, concise, detailed account of the research participants course and status to IRB and principal investigator/study sponsor
• Prepares pertinent research participant information for formal and informal review.
• Ensures research participant eligibility through complete history review and patient interview, consulting principal investigator/sponsor as needed with obscure findings.
• Performs precise drug/device dispensation and collection; maintains accurate accountability logs and inventory, according to governing rules and regulations.
• Is alert to protocol changes that would require amendment in response to research participant safety concerns and consent. Promptly makes necessary changes and reports amendments to the IRB. Obtains written consent and/or verbal to research participants if necessary assuring appropriate documentation.
  
  

• Graduate of an accredited Bachelors degree Nursing program
• Current Registered Nurse (RN) license
• Maintains Basic Life Support (BLS) competency
• Minimum of two years previous RN experience in ambulatory and/or acute care settings
  
  

• Certification from an appropriate accredited certifying body (e.g. ACRP or SOCRA) is strongly preferred.
  
  

• N.A.
  
  

• N.A.
  
  

• Extensive knowledge of research study design, development, artificial intelligence, and disease process is preferred.
• At least three years of related research experience in a healthcare institution.
• At least four years of experience as a registered nurse.
  
  

• +Five years of experience in clinical research and conducting clinical trials and/or clinical studies.