Clinical Research Associate I - Heart Institute - Bairey-Merz Lab

Cedars-Sinai Medical Center

Los Angeles, CA

JOB DETAILS
SKILLS
Administrative Skills, Adverse Events, Budgeting, Cardiac Surgery, Case Report Form (CRF), Clinical Data, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Contact Management, Data Entry, Disease, Drug Therapy, FDA (Food and Drug Administration), Federal Government, Genetic Research, HIPAA (Health Insurance Portability and Accountability Act), IRB/IEC (Institutional Review Board/Independent Ethics Committee), Legal, Maintain Compliance, Medical Billing, Patient Care, Patient Confidentiality, Patient Follow-up, Project/Program Coordination, Quality of Care, Regulations, Regulatory Submissions, Research Administration, Research Nursing, Sociology
LOCATION
Los Angeles, CA
POSTED
10 days ago

Job Description

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 I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. 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 as needed for study and assist with study budget and patient research billing. 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 or Research Nurse 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 patient contact or patient contact for long term follow-up patients only.
  • Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of 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 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.

Qualifications

Education

  • Highschool diploma/GED required
  • Bachelor's Degree in Science, Sociology or related degree preferred

Experience

  • 1-year Clinical Research Related Experience

About the Company

C

Cedars-Sinai Medical Center

Cedars Sinai is one of the largest nonprofit academic medical centers in the United States, and it is the largest private academic medical center in the Western United States. The Cedars Sinai main campus, which encompasses nearly 24 acres, is located at the point where the cities of Los Angeles, Beverly Hills, and West Hollywood meet. Cedars Sinai has been recognized annually by U.S. News & World Report’s top 10 best hospitals in the U.S. The institution most recently placed No. 7 among a select group of 20 Honor Roll hospitals and ranked nationally in a dozen specialties. In addition, Cedars Sinai ranked No. 3 in California and No. 2 in the Los Angeles metro area.

Within Cedars Sinai, the Institute for Research on Health Aging conducts multi-disciplinary research that prioritizes the prevention of cardiovascular disease, neurocognitive disease, and cancer. Our focus is on translating new research discoveries into pragmatic interventions aimed at promoting healthy aging across diverse populations. Our approach involves human physiology, cohort, and clinical trial studies and our team includes established experts in population, clinical, translational, basic, and data science.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Other/Not Classified
WEBSITE
http://www.cedars-sinai.org