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Clinical Research Coordinator I – Geriatric Fracture Program (GFP)
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.
Educational Requirements:
- Bachelor of Science or Bachelor of Arts Degree, required.
License/Certification/Registration Requirements:
- ACRP/SoCRA (or equivalent) certification, preferred
Experience and Skillset:
- Two (2) years of directly related experience, required. Clinical research coordination or clinical research associate/assistant experience, preferred.
- Knowledge of MS Office Suite (Excel, Word, Outlook, PowerPoint) is desired.
- Experience with electronic medical systems. CS-Link experience, preferred.
- Experience developing, maintaining and extracting Redcap databases is a plus.
- Working Title: Clinical Research Coordinator I – Geriatric Fracture Program (GFP)
- Business Entity: Academic / Research
- Job Specialty: Research Studies/Clinical Trials
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Day
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.
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