Clinical Research Associate II - Smidt Heart Institute - Shared Clinical Resource Team (SCR Team)
Los Angeles, California
Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. By joining us in an academic role, you’ll be a part of formulating future ideas for discovery and then translating those discoveries into cures for the benefit and health of the Los Angeles community.
- Full-time & Per-Diem
- Level: Mid to Senior
- Travel: Minimal (if any)
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What makes a successful Clinical Research Associate II - Smidt Heart Institute - Shared Clinical Resource Team (SCR Team) at Cedars-Sinai? Check out the traits we’re looking for and see if you have the right mix.
Discovery is central to Cedars-Sinai’s mission. Our laboratories and clinics generate ideas, therapies, devices, and systems that contribute to biomedical progress around the world. Cedars-Sinai’s investigators push the frontiers of biomedicine with studies in cardiac care, cancer, digestive health, the neurosciences, women’s health, and more. Cedars-Sinai’s robust academic enterprise shapes the experts who will help redefine medicine for the next generation.
ResponsibilitiesRequisition # HRC0763610
As a Clinical Research Associate II working with our Shared Clinical Resource Team (SCR Team), you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. In this role, you will evaluate and abstract research data and ensures compliance with protocol and research objectives. Your position will be responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Will provide limited contact with research participants as needed for study and assist with study budget and research participant billing. In addition, you may coordinate activities, training, and education for other Clinical Research Associates. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
ESSENTIAL JOB 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.
- Assists with clinical trial budgets.
- Assists with patient research billing.
- Schedules research participants 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.
- Serve as the point of contact for external sponsors for select trials.
- May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications.
- May be involved in training and education of other Clinical Research Associates.
- Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives.
- Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
- Bachelor of Arts or Bachelor of Science Degree is strongly preferred
- ACRP/SoCRA (or equivalent) certification preferred.
- One (1) years of directly related experience, or equivalent combination of education and experience
- Working Title: Clinical Research Associate II - Smidt Heart Institute - Shared Clinical Resource Team (SCR Team)
- Department: Heart Institute Operations
- 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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