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Job Description

Grow your career at Cedars-Sinai!

Cedars-Sinai Cancer is committed to pursuing pioneering research into disease mechanism, diagnostic innovations and new technologies and resources. Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, our physicians and scientists are uniquely positioned to guide the next generation of progress against the disease.

Join our team and use your expertise with an organization known nationally for excellence in research studies.

The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. 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).

Primary 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.

• 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.

Qualifications

Educational Requirements: High School Diploma/GED required. BA/BS degree preferred.

Licenses: ACRP/SoCRA (or equivalent) certification preferred.

Experience: 2 years minimum of directly related experience

Req ID : 1374

Working Title : Kidney-Transplant Clinical Research Coord II

Department : Research - Hepatology

Business Entity : Cedars-Sinai Medical Center

Job Category : Academic / Research

Job Specialty : Research Studies/ Clin Trial

Overtime Status : EXEMPT

Primary Shift : Day

Shift Duration : 8 hour

Base Pay : $58,864 - $100,068

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.