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Clinical Research Nurse I
2 months ago
As a Clinical Research Nurse I, you will play a crucial role in the management and execution of clinical research protocols within our Phase 1 Unit. This position requires flexibility in scheduling, with hours ranging from 0 to 40 per week, including potential 12-hour shifts primarily on weekends or doubles. We also accommodate shorter 4-hour shifts for specific studies.
Key Responsibilities:
- Assist in the implementation of protocol activities for Phase I clinical research studies.
- Ensure the safety and confidentiality of all study participants throughout the research process.
- Assess adverse events and manage safety reporting promptly and effectively.
- Review study protocols and informed consent documents, identifying and communicating any potential issues to relevant personnel.
- Engage in nursing activities related to studies in compliance with corporate, divisional, and departmental SOPs, as well as external regulatory guidelines (CFR, ICH, GCP).
- Collaborate with the Principal Investigator, study physicians, and other team members to coordinate study-specific nursing tasks.
- Contribute to quality and compliance improvement initiatives, providing constructive feedback as necessary.
- Maintain precise and complete source data in eSource systems and facilitate the resolution of any discrepancies.
- Support the training of new nursing staff and keep management informed of trainee progress.
- Independently participate in recruitment and screening activities to ensure the appropriate enrollment of subjects in studies.
- Demonstrate essential nursing skills, including IV initiation, computer proficiency, dressing changes, and patient assessments.
Equal Employment Opportunity:
Mindlance is committed to providing equal employment opportunities and does not discriminate based on minority status, gender, disability, religion, sexual orientation, age, or veteran status.