Are you a passionate and dedicated research professional?
The Material and Information Resources for Inflammatory and Digestive Diseases (MIRIAD) Biobank is searching for a Part-Time Clinical Research Coordinator I (CRCI). MIRIAD is the central hub of a full-circle approach to the study of inflammatory bowel disease (IBD). MIRIAD acquires, processes, stores, evaluates and distributes human specimens, which are maintained in association with the triad of accurate longitudinal clinical metadata, comprehensive genotype information and serotypes. These resources are made available to research partners within IBIRI and Cedars-Sinai, and with collaborators around the world. Under the direction of Dr. Jonathan Braun, we are seeking for a hardworking and highly motivated professional to join our efforts!
The CRCI 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 on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular staff meetings. Ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Job Duties and Responsibilities:
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.
Schedules patients for research visits and procedures.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / IRB 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.
Department Specific Duties and Responsibilities:
Ability to follow essential regulatory guidelines and ensures the accuracy and confidentiality of phenotype data.
Responsible for updating patient and other subgroups of active MIRIAD patient's post-surgery outcomes and recurrence through chart-review.
Responsible for collecting the exposures, allergy, and side effects of IBD medication from the selected subgroup of active MIRIAD patients.
Assist with database/data architecture transitions.
Maintains and ensures chart-review IBD consultation notes from Epic and fills out Phenotype Form B1/2 on RedCap.
Chart-review surgery-related data for a list of CD and UC patients and enter the data into RedCap.
Responsible for update via chart-review patients surgery data, include a list of essential surgery data fields for future studies.
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.