Job Description
Responsibilities:
- Clinical Site Management & Compliance
- Regulatory & Protocol Compliance
- Informed Consent Verification
- Monitoring Activities
- Source Document Review & Data Verification
- Protocol Deviations & Safety Monitoring
- Investigational Product (IP) Management
- Data Management & Query Resolution
- Data Quality Oversight
- Tracking & Documentation
- Site & Project Coordination
- Site Training & Delegation
- Communication & Issue Resolution
- Log & Equipment Verification
- Site Audit Preparation & Support
- Collaboration & Training
- Training & Meeting Participation
- Patient Recruitment & Retention
- Escalation & Follow-Up
Requirements:
- Bachelor’s degree in nursing, Life Sciences, Pharmacy, or related field. Registered Nurse (RN) certification is preferred.
- Minimum of 3 years of experience as a Research Nurse, CRA, or similar role within a CRO, clinical trial site, or healthcare setting.
- Strong knowledge of GCP, ICH guidelines, and other regulatory frameworks governing clinical research.
- Proven experience in conducting site monitoring visits, data verification, and patient care within clinical trials.
- Excellent communication, organizational, and problem-solving skills, with the ability to work independently and as part of a team.
- Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems.
- Willingness to travel to clinical sites for monitoring visits, training, and site support.
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