Cedars-Sinai Clinical Research Coordinator I (Cancer Institute) in United States

The Cedars-Sinai Center for Integrated Research in Cancer and Lifestyle (CIRCL) aims to be the preeminent research center studying lifestyle and cancer. The CIRCL strives to provide comprehensive, compassionate cancer care that is scientifically based and rooted in clinical trials to push our knowledge base. We have assembled a multidisciplinary team including epidemiologists, nutritionists, exercise physiologists, translational scientists, basic scientists, clinical researchers, clinicians and statisticians who bring their individual specialties to our common purpose. With all fields working together, we make greater progress to accomplish our goals.

The Clinical Research Coordinator I works independently providing study coordination support for prospective epidemiologic studies and clinical trials supported through the CIRCL and the Survivorship, Lifestyle, and Supportive Health team within the Cancer Center. Responsibilities may include screening of potential participants for protocol eligibility, presenting an overview of study purpose and procedures, participating in the informed consent process, administering questionnaires, and scheduling and follow-up of research study participants. Responsible for accurate and timely data collection, documentation and entry, and reporting including timely response to investigators requests and participants’ questions and concerns. 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. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

ESSENTIAL JOB DUTIES AND 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.

Scheduling of 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 new protocols, continuations, amendments, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

May involve other regulatory / Institutional Review Board duties / and grant submission duties such as budgeting, protocol development, etc.

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.

Participates in required training and education programs.

Coordinates CIRCL meetings including preparing presentations/materials, scheduling, and planning.

May develop and administer surveys and summarize data for analysis.

Acts as a liaison for CIRCL supported investigators.

May assist with CIRCL grant review process.

Education:

BA/BS degree required

Certification/License:

ACRP/SoCRA (or equivalent) certification preferred

Experience:

Two (2) years of directly related clinical research experience