Clinical Research Coordinator
3 weeks ago
| Clinical Research Coordinator
We are seeking a professional, motivated experienced Clinical Research Coordinator with a bachelor’s degree, to join our growing team. In this role, 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. Assists in coordinating study participant activities including recruitment, screening, study visits and correspondence. Ensure 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, enters all research study data following site’s SOP’s. 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, HIPPA, sponsor and site SOP’s. Provides ongoing education to study subjects about clinical trials. Evaluates subject compliance and promotes compliance through education. Assists in the preparation of site for monitor visits and external/internal audits. Provides timely response to queries from sponsor and/or auditors. Maintains accurate accountability of investigation products, specimen 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.
EDUCATION: Bachelor's degree in behavioral health science
Preferred Experience: Knowledge and understanding of federal & state research regulations as well as Good Clinical Practices (GCP) and HIPPA regulations. Proficient with MS Office applications. Demonstrated effective communication and writing skills. Knowledge of medical environment and terminology. Ability to multi-task. Demonstrated ability to work as part of a team as well as independently. IATA certified
Applicants: Along with resume/CV, please include your salary expectations and a short paragraph explaining: Your relevant experience and how it applies to this position What attracts you about this position and how does it fit in your long-term plans.Salary is competitive and will be determined based on education and experience. Job Type: Full-time
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