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SalaryJob Description
Coordinate clinical research studies for the principal investigators and coordinates and promotes research program within St. Elizabeth and the community. Responsible for networking with physicians to open studies, educating staff about current studies, educating patients about studies and obtaining informed consent. Responsibilities include screening and enrolling subjects in studies and managing their participation according to ethical, regulatory, and protocol specific requirements. Responsibilities also include data collection and submission as well as Regulatory compliance
Responsibilities Coordinate clinical research studies conducted by the principal investigator.
Confer with potential study participants to explain the study and obtain informed consent. Review with the participant and family all study requirements including diagnostic procedures, questionnaires, and treatments.
Conduct participant research visits and collect/record research related data. Submit study data to study sponsors as required and enter in patient’s medical record as appropriate. Maintain the integrity and privacy of participant’s research protocol chart with all required source data.
Initiate/coordinate drug orders, laboratory/imaging procedures and treatments for participants based on protocol requirements. Coordinate investigational device/product accountability with St. Elizabeth pharmacy or appropriate clinical department. Coordinate the administration of investigational medication by clinical personnel.
Assist with documentation and submission for approvals, revisions, renewals, informed consents, unanticipated problems, and study closure as mandated by the study sponsors, St. Elizabeth Healthcare, the Institutional Review Board (IRB).
Ensure compliance with protocol guidelines and requirements of regulatory agencies, including required documentation and record retention. Monitor patient’s progress and report adverse events/protocol deviations as required. Participate in quality assurance activities.
Conduct research studies according to the Office for Human Research Protections (OHRP) and US Food and Drug Administration (FDA) regulations and guidelines. Follow Good Clinical Practices, Good Laboratory Practices, St Elizabeth Healthcare policies, and maintains related certifications. For Research Nurse role, perform duties within the scope of the appropriate state Nurse Practice Act.
Obtain patient biological specimens or work with laboratory/clinical nursing staff to obtain laboratory specimens (blood, urine, saliva, etc.). Maintain IATA certification for the safe handling and shipping of biologic specimens.
Work with clinical departments and finance department to ensure appropriate billing/coding of study related activities. Assist with development of research billing grids, budgets, and monitoring of reimbursements. Perform other duties as assigned.
Qualifications
Education, Credentials, Licenses:
Research Nurse applicants: Bachelor’s Degree in Nursing; Graduate from an Accredited School of Nursing. Licensed to practice nursing in the state where work is being performed. Meet contact hour requirements for licensure, including all state-required courses.
Research Coordinator applicants: Bachelor’s Degree in related area of study
Specialized Knowledge Understanding of research processes Ability to effectively manage and prioritize multiple tasks while meeting tight deadlines Proficiency with Excel, Word, Outlook and PowerPoint is imperative
Kind and Length of Experience
Research Nurse applicants: 5 years’ related experience in specialty area
Research Coordinator applicants: 3 years’ related experience in specialty area
If, for any reason, you are having difficulties applying, please contact our recruitment team at recruiting@stelizabeth.com
