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The Chen Laboratory is unraveling basic mechanisms of lung injury and repair. Our focus is on how lung epithelial cells interact with other cellular compartments and with the extracellular matrix to regulate inflammatory cell recruitment and lung fibrosis in various cell-based and animal models. To learn more, please visit: Chen Research Lab | Cedars-Sinai (cedars-sinai.org)
The Clinical Research Associate I (CRA I) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms (CRFs), entering clinical research data, and assist with regulatory submissions to the Institutional Review Board (IRB). The CRA I may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role complies with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
- Enter clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- Provide supervised contact with research participants or contact for long term follow-up research participants only.
- Works closely with supervising research staff or directly with the IRB to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
- Assists with clinical trial budgets, patient research billing and schedules patients for research visits and research procedures
- Responsible for sample preparation and shipping and maintenance of study supplies and kits
- 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 Job Responsibilities:
- Assists with regulatory sponsor paperwork for clinical trials and prescreens potential subjects for various clinical trials
- Chart abstraction for chart review studies
- Attends monthly conference calls with sponsors
- Maintaining organization of various databases
- Maintains awareness and follows-up with ancillary departments to ensure data are received timely
- Tracks research participants for periodic required follow-up, maintains current addresses, contact info, and phone numbers
- Performs literature reviews and searches for manuscripts and research proposals, and proofreads manuscripts, letters, and other documents
- Attends internal research meetings, takes meeting minutes, maintains and distributes accurate minutes
- Maintaining organized files, and e-files; Relaying/running documents between various offices; Obtaining needed signatures on various research documents; Organizing/scheduling/rescheduling research meetings; frequent communication with collaborating institutions; and other departments within institution; maintains current contact information for research collaborators.
- Responds to sponsor emails regarding start up activities and recruitment.
- Bachelor of Art or Sciences degree, or equivalent combination of education and experience.
Experience and Skillset:
- Understanding of general clinical research objectives. Clinical research experience, preferred.
- Working Title: Clinical Research Associate I - Pulmonary - Department Of Medicine
- Department: Home Dept - Pulmonary
- Business Entity: Academic / Research
- City: Los Angeles
- Job Category: 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.
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