We are seeking an experienced and detail-oriented Senior Clinical Research Coordinator to join a dynamic and growing clinical research team. The ideal candidate will have a strong background in clinical trial coordination and will be responsible for independently managing all aspects of assigned clinical studies in compliance with regulatory requirements, sponsor protocols, and internal SOPs.
Key Responsibilities:
- Independently coordinate and manage multiple Phase I-IV clinical trials across various therapeutic areas.
- Serve as the primary point of contact for sponsors, monitors, and regulatory agencies during study conduct.
- Screen, enroll, and follow study participants according to protocol guidelines and Good Clinical Practice (GCP).
- Ensure timely and accurate data collection, entry, and query resolution in electronic data capture (EDC) systems.
- Prepare and maintain essential regulatory documents, including IRB submissions, amendments, and continuing reviews.
- Manage study visit scheduling, patient follow-ups, investigational product accountability, and compliance.
- Train and mentor junior CRCs and other study staff, providing oversight and support when needed.
- Assist in the development and review of study budgets, contracts, and billing compliance processes.
- Participate in site qualification, initiation, monitoring, and close-out visits.
- Ensure adherence to all applicable regulations, including FDA, ICH-GCP, and institutional policies.
Qualifications:
- Fluent in English and Spanish
- Bachelor's degree in a health-related field or equivalent combination of education and experience.
- Minimum of 3-5 years of clinical research coordination experience, preferably in a senior or lead role.
- Strong working knowledge of clinical trial operations, regulatory compliance, and human subject protection.
- Certification as a Clinical Research Coordinator (ACRP or SOCRA) is preferred but not required.