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Senior Clinical Research Coordinator
2 months ago
Position Overview:
The Senior Clinical Research Coordinator plays a pivotal role in managing a designated portfolio of clinical research initiatives, operating autonomously to establish and oversee the logistics and methodologies essential for the execution of research within the department.
This role involves collaboration with principal investigators, study participants, clinical and research personnel, laboratory teams, medical experts, pharmaceutical representatives, and sponsor delegates to effectively implement research protocols while adhering to all relevant regulatory standards.
Key Responsibilities:
- Lead the administrative aspects of clinical research projects, including patient scheduling for study visits, procedures, and laboratory tests, as well as the completion and upkeep of consent forms, case report forms, serious adverse events (SAEs), and source documentation.
- Oversee the screening and recruitment of potential participants to ensure protocol eligibility, clearly communicating non-medical trial concepts and details to patients, and facilitating the informed consent process.
- Ensure accurate and timely data collection, documentation, entry, and reporting, including addressing queries from sponsors or regulatory bodies.
- Coordinate institutional, pharmaceutical, and internal audits, facilitating third-party study monitoring and implementing necessary corrective actions.
- Compile and present study reports, including protocol activity, enrollment data, workload, and other research-related information during regular research staff meetings.
- Ensure timely reporting of adverse events, serious adverse events, protocol deviations, and safety letters in compliance with local and federal regulations.
- Identify opportunities for quality and performance improvement, collaborating with staff to develop actionable plans.
- Strategize and coordinate efforts to enhance research participant enrollment and improve clinical research efficiency as required.
- Provide technical support for grant proposal preparation, publications, presentations, and special projects.
- Assist in the development of research project budgets, distinguishing between routine care and research-related care, and support research participant billing and reconciliation.
- Attend relevant meetings and conferences related to research activities, including research staff meetings.
- Participate in planning sessions, workshops, evaluation meetings, and seminars, contributing to the training and education of new research personnel.
Qualifications:
- Bachelor's Degree (Preferred)
- Minimum of 3 years of experience in clinical research coordination or a related field (Preferred)
- Basic Life Support (BLS) certification from an AHA Healthcare Provider (Minimum)
- Certification in Clinical Research (SoCRA or ACRP certification preferred)
About Cedars-Sinai:
Cedars-Sinai is a prominent institution dedicated to delivering high-quality healthcare, including primary care, specialized medicine, and innovative research. Established in 1902, Cedars-Sinai has continuously adapted to meet the diverse needs of the community, setting benchmarks in quality patient care, research, education, and community service. Today, Cedars-Sinai is recognized nationally for its leadership in advancing healthcare for the benefit of patients, impacting the future of healthcare through new treatment methodologies and the education of future health professionals. The institution is committed to enhancing community health through programs that support its most vulnerable residents.
