Clinical Trials Nurse Manager
6 days ago
The Staffing Resource Group Inc is seeking a highly skilled Clinical Research Nurse to join our team. As a Clinical Research Nurse, you will be responsible for conducting clinical research studies and ensuring the well-being and safety of study participants.
Key Responsibilities- Study Conduct: Conduct clinical research studies in strict compliance with study protocols, Good Clinical Practice standards, Standard Operating Procedures, QA/QC procedures, OSHA guidelines, and other state and local regulations.
- Participant Safety: Monitor the well-being and safety of study participants, providing ongoing assessment and ensuring proper documentation and reporting of Adverse Events.
- Communication: Facilitate verbal directions from the Principal Investigator to study participants and/or clinical study staff, and ensure appropriate follow-through.
- Protocol Review: Assist the Principal Investigator with the review of laboratory data results for the selection and randomization of study participants and for the monitoring of safety parameters.
- AE Reporting: Provide ongoing assessment of the study subject/patient to identify Adverse Events, ensure proper documentation and reporting of all AEs, and provide any appropriate clinical care or instructions to subjects.
- Team Collaboration: Continuously communicate the progress of study conduct to the Principal Investigator, Clinical Study Manager, and members of the clinical study team through various methods of communication.
- SAE Notification: Immediately notify the Principal Investigator, Clinical Study Manager, and members of the clinic management team upon the occurrence or reporting of a Serious Adverse Event by a study participant.
- Participant Satisfaction: Enforce rules and regulations with study participants and handle participant complaints efficiently and effectively, maintaining participant satisfaction.
- Documentation: Maintain compliant, clear, and accurate study charts and documentation of all AEs reported and Concomitant Medication usage throughout the study.
- Leadership: In the absence of the Clinical Study Manager, perform as the floor leader and mentor, assisting research technicians, clinical research nurses, clinical research paramedics, and laboratory technicians as needed on the conduct floor.
- Study Medication Administration: Administer study medication according to study protocol, demonstrate thorough understanding of study medications, and administer concomitant medication as directed by the Principal Investigator.
- Protocol Training: Work with the Clinical Study Manager and Training Manager to provide protocol training to the clinical study team, as well as to communicate on-the-spot performance direction and feedback as needed.
- End of Study Activities: Oversee the completion of all End of Study or Early Termination activities by study participants, inclusive of follow-up for the close-out of any outstanding items.
- Experience: One to two (1-2) years of experience in a clinical research environment.
- Education: A nursing degree and in-state licensure is required.
- Certifications: Advanced Life Support (ALS) required.
- Registration: Requires candidates that are Registered Nurses.
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