Cedars-Sinai Clinical Research Associate II (Heart Institute) in Los Angeles, California
A Clinical Research Associate II is needed to working independently but in close cooperation and in consultation with Dr. Sumeet Chugh, Associate Director, Heart Institute in the NIH-funded Sudden Cardiac Death Prevention Program. The Clinical Research Associate II works directly with Research faculty and staff to facilitate study objectives. The Associate evaluates and abstracts clinical research data entered into an established database. May assist with regulatory submissions to the IRB. Provides limited patient contact as needed for the study. There are opportunities to participate in manuscripts and grant proposals that result from research efforts. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Works with research staff to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Analysis of medical records including a fundamental knowledge of clinical medicine and preferably clinical cardiology terminology and analysis.
Confidence to interact with prospective research subjects on the phone or in person, including ability to conduct detailed interviews or assist with detailed questionnaires
Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with the Principal Investigator or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Responsible for shipping and maintenance of study supplies and kits.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
May be involved in training and education of other Clinical Research Associates.
May coordinate activities of other associates to ensure compliance with protocol and overall clinical research objectives.
May have some percent of effort in centralized activities such as auditing, Standard Operating Procedure development, etc.
Proficient in Microsoft Office, including Word, Excel, PowerPoint, Outlook.
Candidate should have strong communication skills and be comfortable interacting with research subjects.
Bachelor of Science or Bachelor of Arts Degree required, degree in Biological Sciences preferred. Preferred specialty background in Cardiovascular disease
Knowledge of Microsoft Word, Excel and other Windows-based software.
Two (2) years of clinical research or equivalent experience. Applicant must be highly motivated and able to work independently. Must have superior interpersonal, communication and organization skills. Must possess computer skills to include, but not limited to, Excel, Word, PowerPoint, and Outlook. Ability to simultaneously manage multiple tasks, and attention to details. Proficiency in Spanish preferred.
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions