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Clinical Research Coordinator II
2 months ago
Cedars-Sinai is seeking a highly skilled Clinical Research Coordinator II to join our research team. As a key member of our team, you will be responsible for coordinating and executing logistical aspects of clinical research projects, ensuring compliance with regulatory requirements and maintaining the highest level of patient safety.
Key Responsibilities- Project Planning and Coordination: Establish and execute logistical aspects of clinical research projects, including project planning, resource allocation, and developing systems to ensure protocol compliance and patient safety.
- Administrative Functions: 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.
- Patient Recruitment and Screening: 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.
- Data Collection and Reporting: Responsible for accurate and timely data collection, documentation, entry, and reporting, including resolution of queries from sponsors or regulatory entities.
- Audit and Compliance: Coordinates institutional, pharmaceutical, and internal audits, including facilitating third-party study monitoring and designing and implementing needed corrective actions.
- Study Reporting and Presentations: Responsible for compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
- Regulatory Compliance: Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- Quality and Performance Improvement: Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
- Research Participant Enrollment and Efficiency: Plans and coordinates strategies for increasing research participant enrollment and improving clinical research efficiency as needed.
- Grant Proposals and Publications: Provides technical support for the preparation of grant proposals, publications, presentations, and special projects.
- Research Project Budgeting and Billing: Provides assistance with research project budget development, including identifying and classifying routine care vs. research-related care, and provides assistance with research participant research billing and reconciliation.
- Meetings and Conferences: Attends meetings and conferences related to research activities, including research staff meetings.
- Training and Education: Participates in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested; participates in training and education of new research personnel.
- Associate's Degree or College Diploma (Minimum)
- Bachelor's Degree (Preferred)
- 3 years of clinical research coordination or related experience (Preferred)
- Basic Life Support (BLS) Certification, AHA Healthcare Provider Type Only (Minimum)
- Certification in Clinical Research, SoCRA or ACRP (Preferred)
