Clinical Research Coordinator ( {{city}})
The Clinical Research Coordinator (CRC) will be responsible for the organization, coordination, and implementation of clinical trial activities in accordance with Good Clinical Practice (GCP), FDA regulations, and study protocols. This position supports the Principal Investigator and involves direct patient interaction, data management, and liaison with sponsors and monitors.
Key Responsibilities:
- Coordinate and manage clinical trial activities from study start-up to close-out
- Schedule and conduct study visits, obtain informed consent, and maintain subject safety and confidentiality
- Maintain and organize source documentation and regulatory files per protocol and ICH-GCP guidelines
- Collect, record, and enter data into electronic data capture systems (EDC); resolve data queries in a timely manner
- Generate and run system reports to identify and select eligible patients for study enrollment
- Serve as the primary point of contact for sponsors, CROs, monitors, and other stakeholders
- Assist with IRB submissions, updates, and correspondence
- Track inventory and handle investigational product (IP) per protocol guidelines
- Ensure timely and accurate adverse event (AE) and serious adverse event (SAE) reporting
- Prepare for and participate in site monitoring visits, audits, and inspections
Qualifications:
- Bachelors degree in a health-related field preferred; equivalent experience considered
- 13 years of experience as a CRC in a clinical research setting (Phase 2/3 preferred)
- Strong knowledge of GCP, FDA regulations, and clinical trial processes
- Familiarity with running eligibility or enrollment reports within EDC or clinical trial management systems (CTMS)
- Excellent organizational, communication, and interpersonal skills
- Proficiency with EDC platforms and Microsoft Office Suite
- Ability to multitask, prioritize, and work independently in a fast-paced environment
- Bilingual (English/Spanish) preferred
Why Join Us?
- Work with a mission-driven team at the forefront of clinical research
- Be part of impactful work supporting patients with chronic kidney disease
- Flexible hours available part-time position
- Opportunities for career growth as our research network expands
To Apply:
Submit your resume and a brief cover letter via LinkedIn or email:[email protected]
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