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.
|
