Research Nurse Specialist
3 days ago
The Clinical Research Nurse is responsible for facilitating the logistical aspects of assigned study protocols, providing direct nursing patient care, and contributing to protocol implementation. The ideal candidate will have strong clinical research knowledge, excellent communication skills, and experience working in an inter-professional team environment.
This position requires a registered professional nurse who can work collaboratively with the team to ensure proper implementation and conduct of clinical research studies throughout the lifecycle of a protocol. The successful candidate will have the ability to facilitate logistical aspects of assigned study protocols, provide direct nursing patient care, and contribute to protocol implementation.
Key Responsibilities:- Facilitate logistical aspects of assigned study protocols with other research staff according to Good Clinical Practice, standard operating procedures, nursing practices, and sponsor requirements.
- Provide direct nursing patient care including admission, discharge, diagnosis, medication administration, and performance of applicable clinical study-related tests under the direction of the principal investigator or supervising physician.
- Contribute to protocol implementation by setting systems issues, changes to ensure process works across NMH; present information at weekly meetings in an organized fashion; monitor budgets for selected aspects of research studies.
- Attend investigator meetings, coordinate pre-study site visits, study initiation visits, and other study-related visits by Monitors or Sponsor representatives when required.
- Schedule and lead in-house protocol meetings to review study-related procedures, staffing, and visit flow.
- Schedule and coordinate medical needs and coverage for protocol-related procedures.
- Maintain and document all study-related communication including principal investigators, subjects, Sponsors, IRBs, etc.
- Ensure subject instructions for study participation and serve as the primary contact for subjects by being available to handle study-specific questions, concerns, or events.
- Complete all protocol procedures per study requirements.
- Document adverse event/serious adverse event data on appropriate forms and report to the appropriate parties outlined by the study protocol, regulations, and applicable policies.
- Guarantee quality and completeness of source documents collected during the study to assist with overall principal investigator review and approval.
- Enter accurate, complete, and timely data into CRFs using 100% source documentation verification to assist with overall principal investigator review and approval.
- Schedule, lead, and assist with all study-related visits on site and be readily available during visits for corrections, questions, or other study-related needs.
- Supervise document retention, security, and destruction where applicable.
- Complete all necessary training for the position, including study protocol specific training and Health System policies and procedures.
- Train other study-specific research staff in collecting and reporting required data where applicable.
- Maintain research files, design forms as needed, report findings as appropriate, and assist in preparation or review of material for submission to an IRB including reviewing and editing protocols and consent documents where applicable.
- Travel between hospital locations where research is conducted.
- Perform all other functions related to this job and assigned.
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