Cedars-Sinai · 1 month ago
Clinical Research Coordinator II, Hybrid
120 N Robertson Blvd, Los Angeles, CA, 90048, US
Full-time
Hybrid
Mid Level
$28.30/hr - $48.11/hrCedars-Sinai is a leading healthcare organization, and they are seeking a Clinical Research Coordinator II. The role involves independent study coordination, 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. Primary Duties and Responsibilities
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
Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely
Reports test results to appropriate individuals and exercises professional discretion with patient information
Transportation of research medications
Performs research study related assessments and questionnaires
Assists with prescreening of potential research participants for various clinical trials
Attends research meetings and monthly conference calls with sponsors for study updates
Maintains organized paper and electronic research files
Performs all data collection and data entry tasks for department clinical trials
Assists with preparing manuscripts, letters, and other research documents as needed
Responds to sponsor’ inquiries regarding protocol start-up activities and recruitment
Performs literature reviews
Assists with budget development and negotiation in partnership with CTAO and sponsors to ensure budgets are fully compliant with all CSMC policies
May facilitate training and education of other personnel including mentorship for junior research staff to improve workflow efficiencies
Qualification
Required
Independent study coordination including screening of potential patients for protocol eligibility
Presenting non-medical trial concepts and details to the patients
Participating in the informed consent process
Scheduling patients for research visits and procedures
Documenting thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug
Maintaining accurate source documents related to all research procedures
Accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries
Scheduling and participating in monitoring and auditing activities
Compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information
Presenting information at regular research staff meetings
Notifying direct supervisor about concerns regarding data quality and study conduct
Working 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
Ensuring compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board
Maintaining research practices using Good Clinical Practice (GCP) guidelines
Maintaining strict patient confidentiality according to HIPAA regulations and applicable law
Coordinating training and education of other personnel
Participating in centralized activities such as auditing, Standard Operating Procedure development, etc
Planning and coordinating strategies for increasing patient enrollment, and/or improving clinical research efficiency
Identifying quality and performance improvement opportunities and collaborating with staff in the development of action plans to improve quality
Identifying new research opportunities and presenting to investigators
Participating in required training and education programs
Verifying specimen identification, assessing appropriateness of test orders and quality of specimen
Identifying patients and patient samples by strict adherence to established procedures
Labeling samples accurately and completely
Reporting test results to appropriate individuals and exercising professional discretion with patient information
Transportation of research medications
Performing research study related assessments and questionnaires
Assisting with prescreening of potential research participants for various clinical trials
Attending research meetings and monthly conference calls with sponsors for study updates
Maintaining organized paper and electronic research files
Performing all data collection and data entry tasks for department clinical trials
Assisting with preparing manuscripts, letters, and other research documents as needed
Responding to sponsor inquiries regarding protocol start-up activities and recruitment
Performing literature reviews
Assisting with budget development and negotiation in partnership with CTAO and sponsors to ensure budgets are fully compliant with all CSMC policies
Facilitating training and education of other personnel including mentorship for junior research staff to improve workflow efficiencies
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.
Founded in 1902
10001+ employees
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
Thomas Priselac
President/CEO
David Wrigley
Executive Vice President Finance, CFO and Treasurer
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