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Clinical Research Assoc I - RheumatologyRequisition # 19003367 Apply Now
As a Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to assist with coordination and/or implementation of 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, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited contact with research participants as needed for study and assists with study budget and research participant billing. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Essential duties and responsibilities:
- Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse or Principal Investigator to coordinate/implement study.
- Evaluates and abstracts clinical research data from source documents.
- Ensures compliance with protocol and overall clinical research objectives.
- Completes Case Report Forms (CRFs).
- Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- Provides supervised contact with research participants or contact for long term follow-up research participants only.
- Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
- Schedules patients for research visits and research procedures.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
- 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 and/or unit specific essential job responsibilities:
- Enters data from research subject charts into electronic data capture systems.
- Assists with regulatory sponsor paperwork for clinical trials.
- Chart abstraction for chart review studies.
- Pre-screens potential subjects for various clinical trails.
- Maintaining organization of various databases.
- Tracks research participants for periodic required follow-up.
- Maintains current addresses, contact info, phone numbers.
- 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 the institution.
- Maintain current contact information for research collaborators.
- BA/BS degree, or equivalent combination of education & experience.
- Understanding of general clinical research objectives.
- Clinical research experience preferred.
- Working Title: Clinical Research Assoc I - Rheumatology
- Department: Home Dept - Rheumatology
- 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.
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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