Job Description

　　Grow your career at Cedars-Sinai!

　　The Smidt Heart Institute reflects Cedars-Sinai's steadfast commitment to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to an increasing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.

　　Join our team and use your skills with an organization known nationally for excellence in research!

　　Job Summary:

　　Exciting opportunity to work as a coordinator in an ongoing cohort study and new clinical trials at the Center for Cardiac Arrest Prevention (CCAP).

　　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).

　　Duties and Responsibilities:

　　•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.

　　•Schedules and participates in monitoring and auditing activities.

　　•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:

　　BS in Science, Sociology or related degree

　　Licenses:

　　SOCRA or ACRP certification preferred

　　Experience:

　　2 years of clinical research related experience.

　　Ability to use discretion and maintain privacy, confidentiality or anonymity

　　Ability to interpret and apply knowledge of State, Federal and Agency standards to follow regulations

　　Ability to convey and/or receive written/verbal information to/from various audiences in different formats

　　Physical Demands:

　　Standing, Lifting, Walking and Sitting for periods of time.

　　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 : HRC1216166

　　Working Title : Clinical Research Coordinator II - Smidt Heart Institute (Chugh 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 : $28.30 - $48.11

　　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.