UnityPoint Health
Location
Cedar Rapids, Iowa
The research nurse manages all aspects of clinical trials, acting as a liaison between investigators, the IRB, and sponsors. Key duties include screening and enrolling subjects, ensuring protocol compliance, and maintaining accurate regulatory and data documentation.
A Registered Nurse (RN) license is required, with a BSN and oncology certification or experience preferred. Candidates should have clinical research experience and the ability to work independently while meeting strict deadlines.
· The associate is aware of hospital and department compliance for federally funded healthcare programs (e.g. Medicare and Medicaid) regarding fraud, waste and abuse. Brings any questions or concerns regarding compliance to the immediate attention of department or hospital administrative staff. · Purposefully conducts all aspects of the job in an ethical manner in support of the hospital’s commitment to ethical behavior in all areas of personal and professional activity. · Successfully completes hospital-wide orientation, annual hospital competencies and department/unit specific competencies. · For the safety of our patients and co-workers, St. Luke’s Hospital requires seasonal and job related vaccinations. This is reviewed regularly during periodic health assessments. · Ensures sound conduct of the clinical trial, including but not limited to recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements (e.g., subject follow-up, case report form completion, and reporting of adverse drug experiences). · Maintains accurate and complete documentation, including but not limited to signed informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications. · Organizes all aspects of the trial, including but not limited to timeliness in completing case report forms (CRFs), data entry, reporting adverse drug experiences (ADEs), managing caseload and managing study files. · Maintains communication of all protocol-related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial, concerns regarding possible ADEs or subject compliance. · Demonstrates professional conduct in the presence of subjects, research staff, sponsors, monitors · Develops and maintains enrollment/follow-up mechanisms. · Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility. · Review with the principal investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol. · Review and verify all relevant source documentation in the subject’s medical record to confirm study eligibility. · Ensure adherence to protocol requirements. · Maintain copies of all prescriptions written for study drug supplies, as appropriate. · Ensure appropriate specimen collection. · Attend study-related meetings as appropriate. · Communicate regularly with the principal investigator about study-related issues. · Case report form (CRF) preparation and study documentation and ensures timely and accurate CRF completion for each study subject.
RN Required, BSN Preferred. Oncology certification or experience working within the oncology field preferred. Clinical research-related experience preferred Experience organizing multiple tasks, working with diverse groups of people. Ability to work independently and self-direct work activities. Detailed oriented and able to meet established deadlines.
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