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Cedars-Sinai · 1 month ago

Clinical Research Coordinator II - Pancreatic Research Program

8700 Beverly Blvd, Los Angeles, CA, 90048, US

Full-time

Onsite

Mid Level

$59K/yr - $100K/yr

Cedars-Sinai is a leading medical institution focused on advancing healthcare through innovative research. The Clinical Research Coordinator II will support the Pancreatic Research Program by coordinating studies, ensuring compliance with regulations, and enhancing patient outcomes for conditions such as pancreatic cancer and diabetes.

CommunitiesHealth CareMedicalNon Profit

Comp. & Benefits

Responsibilities

Screening of patients for protocol eligibility, presenting non-medical trial concepts and details

Schedules patients for research visits and procedures

In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug

Maintains accurate source documents related to all research procedures

Schedules and participates in monitoring and auditing activities

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

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 identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality

Participates in required training and education programs

Qualification

Clinical Research CoordinationClinical Practice (GCP)Regulatory ComplianceData CollectionPatient ScreeningPatient ConfidentialityTraining CoordinationTeam Collaboration

Required

Experience in clinical research coordination

Knowledge of Good Clinical Practice (GCP) guidelines

Familiarity with federal and local regulations including FDA and IRB

Ability to maintain strict patient confidentiality according to HIPAA regulations

Strong organizational and communication skills

Experience with data collection, documentation, entry, and reporting

Ability to screen patients for protocol eligibility

Experience in scheduling patients for research visits and procedures

Ability to document changes in patient condition, adverse events, and protocol compliance

Experience in maintaining accurate source documents related to research procedures

Ability to notify supervisors about data quality and study conduct concerns

Experience in submitting Adverse Events and protocol deviations to IRB

Ability to coordinate training and education of other personnel

Participation in required training and education programs

Company

Cedars-Sinai

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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