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Cedars-Sinai Clinical Research Coordinator II - Research Center for Health Equity in Los Angeles, California

Join the Research Center for Health Equity as a Clinical Research Coordinator and help us make a difference.

Developed as a part of the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai, the Research Center for Health Equity (RCHE) conducts a wide range of research, from molecular/genetic to behavioral, and research-driven community outreach and engagement (COE). COE efforts focus on compliance with cancer screening guidelines and major behavioral and lifestyle factors, such as physical activity, tobacco cessation and dissemination of the latest, most accurate cancer information. To increase effectiveness and extend our reach, the Center has established partnerships with many diverse community organizations in Los Angeles county and statewide. The center has also established research consortia at the statewide, national, and international levels.

The Clinical Research Coordinator II- RCHE will work independently providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. May plan and coordinate strategies for increasing research participant enrollment, improving efficiency, training of personnel, or identifying new research opportunities. The coordinator will provide day-to-day support to the investigative team in implementing clinical research projects and providing support to meet deliverables. The coordinator will also assist with the production of intervention and assessment materials. Coordinate the investigative team meetings, and will serve as the liaison between the research team and community/clinical partners. She/he will work with clinical and community personnel in coordinating training, intervention and data collection activities. The CRC II will assist with the development and submission of project-related approvals, including IRB applications, amendments, and renewals,

In addition, the Clinical Research Coordinator II- RCHE will be responsible for the following:

  • Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

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

  • Responsibilities may include assisting in grant submissions and the preparation of scholarly presentations and posters for local, national and international conferences and meetings as well as progress reports to the funding agency. She/he will also assist with processing study-related purchases, participant incentive payments, and overseeing data entry, the preparation of internal reports, and other study activities as directed.

  • Development of study material including proposals, protocols, intervention manuals and assessment forms.

  • Development and submission of project-related approvals, including IRB applications, amendments, and renewals, as well as progress reports.

  • Conduct assessments with study participants.

  • Data entry and monitoring data collection.

  • Coordinate study meetings and work with other staff.

  • 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.

  • May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.

  • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.

  • Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.

  • Coordinates training and education of other personnel.

  • Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.

  • Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.

  • Identifies quality and performance improvement opportunities and collaborates 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.

  • Other Duties As Assigned

Educational Requirements:

BA/BS degree.

License/Certification/Registration Requirements:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

Four (4) years minimum of clinical research coordination.

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

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