Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
Note: This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired, you must reside in the commutable area.
About the Teams
Ongoing advances in science and technology make it possible to explore the causes of disease at the genetic level. The Cedars-Sinai Biobank is a place where biological samples, such as tissue, blood and urine, are stored along with selecting health information for later use in biomedical research. Researchers use the Biobank like a library, accessing samples with diverse genetic characteristics to explore answers to scientific questions.
The goal of our stroke research is to conduct groundbreaking and practice‑changing stroke research, deepening our understanding of the cause of stroke, best strategies for stroke prevention, and enhanced stroke recovery.
About the Role
The Clinical Research Coordinator I will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The CRC I member is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents study information at research staff meeting. This position ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Primary Duties and Responsibilities:
Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
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 following local and federal guidelines.
May perform other regulatory/Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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 training and education of other personnel.
Department-Specific Duties and Responsibilities:
Transportation of research medications.
Performs research study related assessments and questionnaires.
Assists with prescreening of research participants for various clinical trials.
Attends research meetings and monthly conference calls with sponsors for study updates.
Maintains organized paper and electronic research files.
Performs all data collection and data entry tasks for department clinical trials.
Assists with preparing manuscripts, letters, and other research documents as needed.
Responds to sponsor’ inquiries regarding protocol start-up activities and recruitment.
Performs literature reviews.
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.
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.