Under the direction of Dr. Megan Hitchins, t he Hitchins Laboratory undertakes translational cancer research with a focus on genetic and epigenetic alterations associated with cancer, in particular cancer-specific changes in DNA methylation. Researchers in the Hitchins Lab undertake studies on genetic and epigenetic alterations that predispose to cancer onset, as well as the discovery and development of epigenetic alterations to serve as tumor biomarkers for applications to cancer diagnosis, prognosis or prediction of treatment outcomes.
Are you a passionate and dedicated researcher? The Hitchins Laboratory is currently seeking a Clinical Research Coordinator III (CRCIII)!
The CRC III 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. This role is responsible for oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff.
Additional Job Duties and Responsibilities:
Plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research opportunities.
This position will require the provision of phlebotomy services and limited blood sample processing.
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.
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 involve 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.
Participates in required training and education programs.
Works 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.
Plans and coordinates strategies for increasing patient 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.
Identifies new research opportunities and presents to investigators.
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 teaching 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.