Clinical Research Coordinator II
2 weeks ago
Cedars-Sinai is seeking a highly skilled Clinical Research Coordinator II to serve as the lead coordinator on an assigned portfolio of research studies. This individual will be responsible for establishing and coordinating logistics and processes for the conduct of research, ensuring compliance with all applicable regulatory requirements.
Key Responsibilities- Coordinate administrative functions of research studies, including scheduling of patients for research visits, procedures, and labs, and completion and maintenance of consent forms, case report forms, SAEs, and source documents.
- Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to patients, and supporting the informed consent process.
- Accurate and timely data collection, documentation, entry, and reporting, including resolution of queries from sponsors or regulatory entities.
- Coordinate institutional, pharmaceutical, and internal audits, including facilitating third-party study monitoring and designing and implementing needed corrective actions.
- Responsible for compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information.
- Timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
- Plan and coordinate strategies for increasing research participant enrollment and/or improving clinical research efficiency as needed.
- Provide technical support for the preparation of grant proposals, publications, presentations, and special projects.
- Assist with research project budget development, including identifying and classifying routine care vs. research-related care, and provide assistance with research participant research billing and reconciliation.
- Bachelor's Degree (Preferred)
- 3 years Clinical research coordination or related experience (Preferred)
- Basic Life Support (BLS) Basic Life Support Certification needs to be the AHA Healthcare Provider Type Only (Minimum)
- Certification In Clinical Research SoCRA or ACRP certification (Preferred)
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine, and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching, and community service.
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