Title: Sr. Clinical Research Coordinator
Location: Charleston, WV (**They are willing to relocate someone for this position!!)
Opportunity: opportunity to quickly move into a Site Manager and/or Site Director at this company
Job Summary:
The Senior Clinical Research Coordinator is responsible for the overall management of clinical trials and research studies. This role involves coordinating and overseeing all aspects of clinical research, including subject recruitment, regulatory compliance, data collection, and study documentation. The Senior CRC ensures that studies are conducted in accordance with protocols, Good Clinical Practice (GCP), and regulatory requirements.
Key Responsibilities:
Study Coordination:
- Oversee the implementation and daily management of clinical trials.
- Develop and maintain study-related documentation including protocols, informed consent forms, and case report forms (CRFs).
- Coordinate and schedule study visits, including screening, enrollment, follow-up, and close-out visits.
Regulatory Compliance:
- Ensure adherence to all regulatory requirements, including Institutional Review Board (IRB) submissions and approvals.
- Prepare and submit regulatory documents to the IRB and other regulatory agencies as required.
- Maintain compliance with Good Clinical Practice (GCP) and study protocols.
Subject Recruitment and Management:
- Identify, recruit, and screen potential study subjects.
- Obtain informed consent from study participants and ensure their understanding of the study procedures.
- Monitor subject progress and manage any adverse events or issues related to participant safety.
Data Management:
- Ensure accurate and timely data collection, entry, and reporting.
- Monitor data for completeness and consistency, and resolve any discrepancies.
- Maintain and manage study databases and electronic data capture systems.
Team Leadership and Training:
- Supervise and mentor junior CRCs and other research staff.
- Provide training on study protocols, regulatory requirements, and best practices.
- Coordinate with other departments and external stakeholders to ensure smooth study operations.
Study Documentation and Reporting:
- Prepare and review study reports, publications, and presentations.
- Maintain comprehensive and organized study files and records.
- Conduct regular audits to ensure compliance with study protocols and regulations.
Budget and Resource Management:
- Assist in the preparation and management of study budgets and financial reports.
- Monitor study expenses and ensure that they are within budgetary constraints.
Continuous Improvement:
- Stay updated with the latest developments in clinical research and regulatory guidelines.
- Implement process improvements and best practices to enhance study efficiency and quality.
