Clinical Research Nurse Specialist
3 weeks ago
Job Summary:
The Research Nurse Coordinator will play a crucial role in ensuring the integrity and quality of clinical trials at Associated Urological Specialists LLC. Under the guidance of the Principal Investigator and Medical Director, this position will be responsible for maintaining compliance with federal, state, and local regulations, as well as ICH/GCP guidelines and Institutional Review Board approvals.
This position requires a detail-oriented individual with excellent organizational skills, who can prioritize tasks and communicate effectively with patients, investigators, sponsors, and protocol vendors. The successful candidate will be responsible for recruitment, data collection, and documentation, as well as maintaining regulatory documents and institutional SOPs.
Key Responsibilities:
- Ensure compliance with each study's protocol by providing thorough review and documentation at each study visit
- Perform medical tests, including patient vital signs, EKGs, phlebotomy, and nursing assessments
- Administer investigational medications and perform drug accountability
- Query patients for adverse events and notify the PI to determine causality and grading
- Provide accurate and timely data collection, documentation, entry, and reporting in sponsor and CRIO databases
- Complete required training, including GCP, IATA, and specific protocol requirements
- Submit and maintain regulatory documents for all protocols during start-up, maintenance, and close-out
- Develop and maintain institutional SOPs
- Communicate and collaborate with patients, investigators, sponsors, IRB, and protocol vendors
- Responsible for recruitment of patients and assessing eligibility requirements for protocols
Requirements:
- Active RN License for the state
- Basic computer skills
- Attention to detail
- Exceptional interpersonal skills
- Excellent organizational skills
- Ability to prioritize a variety of tasks
- Outstanding written and verbal communication
- Flexibility with hours
- Bachelor's degree
- 1-3 years of experience preferred, but not required
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