Clinical Research Coordinator/CRC
We are seeking a professional, motivated, and experienced Clinical Research Coordinator with a Certificate in phlebotomy to join our growing team. In this role, the CRC will have the opportunity to work on CNS and Alzheimer’s studies, provide a range of study-related services, and assist the investigator or other staff with aspects of sponsor-initiated research studies. Regulatory experience is a plus.
Key Responsibilities:
- Screens for eligibility criteria and assists in coordinating study participant activities including recruitment, screening, study visits, and correspondence.
- Ensures study procedures are followed and research is performed as described in the protocol. Serves as contact for subjects, study personnel, IRB, and study sponsor.
- Collects, records, and enters all research study data following site’s SOPs.
- Maintains accurate, complete, and timely records, including source documents, consent forms, case report forms, protocol documents, and data management.
- Assists with submission of timely, accurate, and complete study continuing review, amendments, and reportable events to IRB.
- Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, sponsor, and site SOPs.
- Provides ongoing education to study subjects about clinical trials.
- Evaluates subject compliance and promotes compliance through education.
- Assists in the preparation of the site for monitor visits and external/internal audits. Provides timely responses to queries from sponsors and/or auditors.
- Maintains accurate accountability of investigation products, specimens, and study-related supplies.
- Assists with sample collection, processing, and shipment for each study. Updates automated databases and other records for reporting, recruitment, and compliance purposes.
- Attends Investigator meetings and other events related to project efforts.
- Participates in educational opportunities to increase knowledge about clinical trials and regulations.
- Orders supplies and equipment.
- Performs other related duties as assigned or requested.
Preferred Experience:
Knowledge and understanding of federal & state research regulations as well as Good Clinical Practices (GCP) and HIPAA regulations. Proficient with MS Office applications. Demonstrated effective communication and writing skills. Knowledge of the medical environment and terminology. Ability to multi-task. Demonstrated ability to work as part of a team as well as independently. IATA certified.
Salary: Salary listed is a range based on experience.
Benefits:
- 401(k) matching
- Bonus based on performance
- Free uniforms
- Opportunity for advancement
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