Cedars-Sinai · 2 days ago
Clinical Research Coordinator II (Remote) Per Diem - 6 months TEMP
Cedars-Sinai is a leading medical center that offers flexible per diem positions. The Clinical Research Coordinator II is responsible for independent study coordination, including patient screening, data collection, and ensuring compliance with regulatory guidelines.
CommunitiesHealth CareMedicalNon Profit
Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process
Schedules patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug
Maintains accurate source documents related to all research procedures
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries
Schedules and participates in monitoring and auditing activities. 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
Notifies direct supervisor about concerns regarding data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board
Maintains research practices using Good Clinical Practice (GCP) guidelines
Maintains strict patient confidentiality according to HIPAA regulations and applicable law
May coordinate training and education of other personnel
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality
May identify new research opportunities and present to investigators
Participates in required training and education programs
Qualification
Required
High School Diploma/GED required
Preferred
2 years Clinical research related experience required
Bachelor's Degree Science
Technical proficiency with clinical trial management systems and databases
Strong organizational and time-management skills
Good understanding of medical terminology
High attention to detail and accuracy
Company
Cedars-Sinai
Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.
Funding
Current Stage
Late StageTotal Funding
$63.31MKey Investors
American Academy of Orthopaedic SurgeonsCalifornia HealthCare FoundationNational Heart, Lung and Blood Institute
2023-12-01Grant· $0.01M
2023-05-25Grant· $28M
2022-06-16Grant· $7M
Leadership Team
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