Clinical Research Coordinator
1 week ago
We are seeking a skilled Clinical Research Coordinator to join our team at Viking Clinical Research. The ideal candidate will have a Certificate in phlebotomy and experience in coordinating study participant activities, including recruitment, screening, and study visits.
Key Responsibilities:- Screen participants for eligibility criteria and assist in coordinating study activities.
- Ensure study procedures are followed and research is performed as described in the protocol.
- Collect, record, and enter all research study data following site SOPs.
- Maintain accurate and complete records, including source documents, consent forms, and case report forms.
- Assist with submission of timely and accurate study continuing review, amendments, and reportable events to the IRB.
- Ensure the consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, and sponsor SOPs.
- Provide ongoing education to study subjects about clinical trials.
- Evaluate subject compliance and promote compliance through education.
- Assist in preparing the site for monitor visits and external/internal audits.
- Maintain accurate accountability of investigation products, specimens, and study-related supplies.
- Assist with sample collection, processing, and shipment for each study.
- Update automated databases and other records for reporting, recruitment, and compliance purposes.
- Attend Investigator meetings and other events related to project efforts.
- Participate in educational opportunities to increase knowledge about clinical trials and regulations.
- Order supplies and equipment.
- Perform other related duties as assigned or requested.
Preferred Experience:
- Knowledge and understanding of federal and 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.
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Clinical Research Coordinator
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