At Cedars-Sinai, we're motivated by a collective spirit of innovation and the challenge to continuously improve. Above all, we share a real passion for helping others. This is just one of the many reasons U.S. News & World Report has named us one of America's Best Hospitals--and now we invite you to join us and make a difference every single day in service of this outstanding work - excellence and innovation in patient care, research, and community service. From working with a team of committed professionals to using state-of-the-art facilities, you'll have great resources to do something incredible--for yourself, and for others!
Are you looking to contribute to pioneering research? We look forward to having you join our team!
The Clinical Research Coordinator II works independently providing study coordination including screening of potential research participants 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 this information at regular research staff meetings. May plan and coordinate strategies for increasing research participant 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).
Essential Job Responsibilities
Scheduling of research participants 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 research participant 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 IRB to submit initial applications, amendments, continuing reviews, 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 research participant billing and reconciliation.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict research participant confidentiality according to HIPAA regulations and applicable law. Coordinates training and education of other personnel.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Plans and coordinates strategies for increasing research participant enrollment, and/or improving clinical research efficiency.
Identifies quality and performance improvement opportunities and collaborates 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.
Department Specific Job Responsibilities
Exciting opportunity to join a dynamic, multi-disciplinary research team for a newly funded trial focusing on intermittent fasting in colorectal cancer. The position will involve onboarding recruited participants into the active intervention and control arms, monitoring the delivery fidelity and weekly one-on-one behavioral counseling in-person or remotely via Zoom. The goal of the counseling is to foster adherence, retention, and accountability; troubleshoot intervention barriers; and monitor safety endpoints. The CRC will further provide support to participants to ensure adherence to protocols using a variety of techniques and strategies (e.g., goal setting, behavioral contracting, and motivational interviewing). The CRC will report to highly collegial and experienced faculty members. The candidate will also have the opportunity to work with numerous other faculty members across a variety of fields, including psychology, cancer epidemiology, obesity and diabetes behavioral interventions and biostatistics.
Onboard, randomize and explain study protocol to recruited participants (active intervention and control arms).
Assist with the development and implementation of study protocols to monitor dosage and intervention integrity.
Monitor data and clinical implementation quality.
Coordinate research interns providing support to project functions as needed.
BA/BS degree, required.
Degree in psychology, counseling, or nutrition, preferred.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.