Job Description

　　Job Summary: Key Job Responsibilities

　　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. Presents 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.

　　•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.

　　•May coordinate training and education of other personnel.

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

　　•May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.

　　•May identify quality and performance improvement opportunities and collaborate 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

　　Qualifications

　　Educational Requirements:

　　Highschool diploma/GED required

　　Bachelors degree in related field preferred

　　Licenses:

　　SOCRA or ACRP certification preferredExperience:

　　2 years clinical research or related experience requiredPhysical Demands:

　　Able to perform moderate lifting.

　　Able to sit, stand and walk for prolonged periods of time.

　　Able to read papers and online documents.

　　Able to operate standard office equipment.

　　Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

　　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 : HRC0960930

　　Working Title : Clinical Research Coord II/S.Cheng Lab

　　Department : Heart 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 : $64,500 - $100,000

　　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.