Are you a passionate and dedicated research professional?
The Cedars-Sinai Geriatric Fracture Program (GFP) provides high-value, geriatric-centered care that manages the injury in the context of the patient as a whole, and strives to return the patient to a meaningful life in a timely manner. Our experts in Gerontology and bone health provide fracture care to help prevent future falls and injuries, as well as promote recovery.
The CRCI works independently providing study coordination including screening and recruitment 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; presents 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
May supervise Clinical Research Associates on data entry, data query and resolution.
Department Specific Duties and Responsibilities:
Interact with the Principal Investigators (PIs), Geriatric Subjects, Clinical Research Staff, Health Coach for Bone Health, Orthopaedic Research Intern, and Medical Professionals.
Maintains daily and coordinates the use of the Geriatric Fracture Program database.
Maintains and coordinates Cedars-Sinai input to the Own the Bone database.
Responsible for administrative functions of research studies, including scheduling of patients for research visits, procedures and labs and completion and maintenance of consent forms, case report forms, and source documents.
Supports clinical research and quality improvement efforts.
Coordinates logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
Support GFP and Bone Health (Own the Bone) data collection, management and related IRB Research.
Responsible for accurate and timely data collection, documentation, entry and reporting, including timely response to sponsor queries.
Acts as liaison and coordinates efforts with other departments and personnel.
Provides assistance with research finance billing, including identifying and classifying routine care vs. research related care.
Attends meetings and conferences related to research activities, including research staff meetings.
Participates in planning, workshops, evaluation meetings and seminars, education or administrative meetings as necessary or requested.
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.