Job Description
Job Summary
- The Research Nurse/Clinical Research Associate (CRA) plays a vital role in ensuring the integrity, compliance, and successful execution of clinical trials.
- This role involves rigorous site management, including monitoring, data verification, patient care, and protocol adherence, to ensure that clinical trials meet all regulatory, GCP, and protocol standards and responsible for tracking and reporting on site performance, ensuring informed consent processes are properly managed, and supporting audit readiness across the study lifecycle.
Key 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
Job 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.