Clinical Research Coordinator

About the Role: Clinical Research Coordinator (CRC)

We are seeking a detail-oriented Clinical Research Coordinator (CRC) to manage and oversee the daily operations of clinical trials. In this role, you will act as the vital link between the clinical site, the study sponsors, and the regulatory bodies, ensuring that all research is conducted with the highest integrity, patient safety, and adherence to strict regulatory standards (such as ICH-GCP and FDA 21 CFR ).

Core Responsibilities

• Study Management: Coordinate the daily activities of clinical trials, including patient recruitment, screening, enrollment, and follow-up visits.
• Regulatory Compliance: Maintain comprehensive Essential Document files and ensure all study activities align with IRB/IEC requirements and SOPs .
• Data Integrity: Perform accurate data entry into Electronic Data Capture (EDC) systems and ensure the "ALCOA+" principles of data integrity are upheld.
• Patient Safety: Monitor participant well-being, report Adverse Events (AEs) and Serious Adverse Events (SAEs) promptly to sponsors and regulatory boards.
• Quality Assurance: Author and maintain source documentation and assist in internal and external audits to ensure GxP and cGMP requirements are met.
• Site Liaison: Serve as the primary point of contact for Clinical Research Associates (CRAs) during monitoring visits.

Qualifications

• Education: Bachelor’s degree in Life Sciences, Nursing, Biomedical Sciences, or a related healthcare field (Required).
• Experience: 0–5 years of experience in clinical research, healthcare administration, or academic laboratory environments.
• Technical Skills (Required):
• Strong understanding of ICH-GCP guidelines and Human Subjects Protection .
• Proficiency in clinical trial management software and EDC platforms.
• Familiarity with 21 CFR Part 11 regarding electronic records and signatures.
• Excellent medical writing and documentation skills.
• Preferred Skills:
• Certification (or eligibility) for CCRC (ACRP) or CCRP (SoCRA).
• Experience with medical device clinical trials (ISO 14155).
• Knowledge of Phlebotomy or basic clinical assessment skills.

What We Offer

• Targeted Placement: Direct marketing to our network of hiring managers in the Life Sciences and MedTech industries.
• Technical Resume Rebuild: Optimization of your profile to highlight clinical expertise alongside regulatory documentation skills.
• Interview Coaching: Guidance on behavioral interviews and regulatory compliance case studies.