Clinical Research Associate II - Smidt Heart Institute Chugh Lab
Cedars-Sinai Medical Center
Location: Los Angeles, California
Internal Number: HRC1338159
Grow your career at Cedars-Sinai!
The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Join our team and use your skills with an organization known nationally for excellence in research!
The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact with research participants as needed for study and assist with study budget and patient research participant research billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary 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. • 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. • 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. May be involved in training and education of other Clinical Research Associates. • Serves as the point of contact for external sponsors for select trials. • 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. • May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
- Highschool diploma required - Bachelor's degree preferred
No license required - SOCRA or ACRP certification preferred
- 1 year clinical research related experience required
- 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.
Working Title: Clinical Research Associate II - Smidt Heart Institute Chugh Lab Department: Heart Institute Operations Business Entity: Cedars-Sinai Medical Center Job Category: Academic/Research Job Specialty: Research Studies/Clinical Trials Position Type: Full-time Shift Length: 8 hour shift Shift Type: Day Base Pay:$21.26 - $36.14
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding oppor...tunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.