Position Summary:
The Clinical Research Coordinator (CRC) is responsible for managing and coordinating clinical trials and research studies under the supervision of a Principal Investigator (PI). This role ensures compliance with regulatory requirements, ethical standards, and study protocols while maintaining high-quality data collection and participant care.
Key Responsibilities:
Study Coordination:
- Oversee day-to-day operations of clinical trials.
- Ensure adherence to study protocols, Good Clinical Practice (GCP), and regulatory guidelines.
- Schedule and conduct participant visits, interviews, and follow-ups.
- Supervise research staff and volunteers, providing guidance and training to maintain high standards of study conduct.
Data Management:
- Collect, code, and enter research data into databases.
- Maintain accurate and complete study documentation, including case report forms and consent forms.
- Monitor data quality and resolve discrepancies.
Regulatory Compliance:
- Prepare and submit IRB documentation and amendments.
- Report adverse events and serious adverse events according to protocol, sponsor, IRB, and regulatory requirements.
- Ensure all study activities comply with FDA, OHRP, and institutional policies.
- Assist in audits and monitoring visits.
Participant Engagement:
- Recruit, screen, and enroll eligible participants.
- Educate participants on study procedures, risks, and benefits.
- Monitor participant safety and report adverse events.
Collaboration & Communication:
- Liaise with sponsors, CROs, labs, and other stakeholders.
- Coordinate with internal departments for study logistics.
- Provide regular updates to the PI and research team.
- Identify workflow improvements that enhance recruitment, enrollment, and study efficiency.
Qualifications & Skills:
- 2-3 years of clinical research coordination experience.
- Bachelor’s degree in a healthcare related field.
- Certification in clinical research (e.g., ACRP or SOCRA)
- GCP and/or IATA Certification
- Strong understanding of clinical trial processes and regulatory frameworks.
- Excellent organizational, communication, and interpersonal skills.
- Proficiency in electronic data capture systems and Microsoft Office Suite.
- Experience in nephrology, chronic kidney disease (CKD), dialysis, vascular access, or related therapeutic areas.
Work Environment:
- Typically based in Ambulatory Surgical Centers and Nephrology private research organizations.
- May require occasional travel for multi-site studies.
- Flexible hours depending on study demands.
- Growing research program with opportunities for professional development and advancement.
Pay: $20.00 - $30.00 per hour
Education:
Experience:
- Clinical research: 2 years (Required)
Language:
License/Certification:
- IATA Certification (Preferred)
Willingness to travel:
Work Location: In person
