9781 - Clinical Research Nurse I
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Will initiate, conduct, complete and report clinical studies in Pediatric Pulmonary, Allergy and Sleep Medicine. Assign and coordinate activities of study sites to ensure protocol, regulatory and standard operating procedures and good clinical practice compliance. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research.
Duties and responsibilities include but are not limited to, participating in the evaluation of research protocols including study design and risk to target population. Accessing and extracting information for protocol development. Assessing target population/availability. Assisting in determining staff, facility and equipment availability. Will participate in protocol development and budget development; compose and prepare regulatory/IRB documents for new study submissions, amendments, continuing reviews and close-out. Develop a worksheet for standard of care versus study specific procedures. Will recruit subjects according to IRB-approved protocols. Schedule study visits, complete all necessary pre-visit tasks and execute study procedures according to protocols and clinical needs. Ensure appropriate informed consent processes are followed. Complete all required documentation related to study visits. Will order and receive drug/device supplies for studies and maintain appropriate inventory. Maintain regulatory records for all medications and devices, including but not limited to logs for medication, dispensing logs, dates of expiration and refrigerator logs. Administer study drugs as indicated by IRB-approved protocols. Capture and record adverse event data and relevant information. Review adverse event information and assist the PI in determining submission and reporting of adverse events. Monitor for protocol compliance. Document and report protocol deviations. Communicate with PI regarding changes in protocols. Prepare and manage monitor visits. Maintain documents as required by Regulatory guidelines. Understand and follow IRB guidelines. Conduct study-related and clinical-related assessments, interventions and monitoring according to protocols and institutional policies.
|Required: Bachelor’s degree in Nursing from an accredited institution, plus 1 year of pediatric clinical nursing experience; or Associate’s degree in Nursing from an accredited institution, plus 3 years of pediatric clinical nursing experience. RN required. |