Clinical Research Nurse II

5 days ago


Orlando, Florida, United States Nemours Foundation Full time
Job Summary

We are seeking a highly skilled Clinical Research Nurse II to join our team at Nemours Foundation. The successful candidate will be responsible for coordinating, implementing, and completing clinical research studies and/or clinical trials.

Key Responsibilities
  • Assist in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases
  • Perform nursing procedures: IV placement, administration of investigational agents through IV or Subcutaneous or Intramuscular injections. Serve as a mentor to research team members and investigators
  • Follow all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collect and prepare documents as required by sponsoring agencies; attend Investigator Meetings, as assigned
  • Understand and conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
  • Participate in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements
  • Perform clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintain multiple study databases. Ability to be submit data proactively and address queries in a timely manner
  • Participate in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance
  • Assist in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
  • Assist in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
  • Prepare clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
  • Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS
  • Participates in continuous process improvement initiatives and implementation of outcomes
  • Prepares for internal and external audits. Prepares corrective action plans as indicated
Requirements
  • Bachelor's degree in Nursing required, Master's degree in Nursing acceptable, demonstrates ability to coordinate and establish priorities among diverse tasks; effectively communicates verbally and in writing
  • Minimum 2 years experience as a Clinical Research Nurse I or Clinical Research Coordinator I


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