Job Description

　　Come join our team!

　　The Clinical Research Coordinator III (CRC-III) provides support from initiation through closeout for all Guerin Children's clinical research studies, including ancillary service coordination, patient recruitment and enrollment, data collection, and compliance assurance. The CRC-III is an experienced coordinator with ample prior clinical trial experience in order to assist with multiple studies at one time, across various specialties, and of differing classifications. The CRC-III is accountable for rapid study start-up, ensuring timely attainment of study milestones, as well as building and maintaining strong relationships with sponsors and internal collaborating offices.

　　Primary Duties & Responsibilities:

　　Responsible for oversight of all studies and the assignment of studies to clinical research personnel within the group. Manages the research portfolio and daily operations for the investigator or disease group.

　　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.

　　Maintain 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.

　　Schedule and participate 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.

　　Notify direct supervisor about concerns regarding data quality and study conduct.

　　Work 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 involve other regulatory / IRB duties, budgeting duties, and assisting with patient research billing and reconciliation.

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

　　Maintain research practices using Good Clinical Practice (GCP) guidelines.

　　Maintain strict patient confidentiality according to HIPAA regulations and applicable law.

　　Participate in required training & education program. Work with Training and Education Coordinator to ensure all staff is properly trained and certified.

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

　　Plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.

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

　　Identify new research opportunities and presents to investigators.

　　Supervise other research staff.

　　Qualifications

　　Qualifications:

　　High School Diploma/GED required. Bachelor's Degree in Science, Sociology, or related degree preferred

　　Certification in Clinical Research (e.g. SOCRA or ACRP) preferred

　　4 years of clinical research related experience required. 5-7 years of directly related experience strongly preferred.

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　　About Us

　　Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.

　　About the Team

　　Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.

　　Req ID : HRC1376210A

　　Working Title : Clinical Research Coordinator III - Guerin Children's - Pediatrics (On-Site)

　　Department : Childrens Health Institute

　　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 : $71300 - $121000

　　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.