Clinical Research Associate I

2 weeks ago

San Diego, California, United States CEDARS-SINAI Full time
Job Overview

The Clinical Research Associate I operates autonomously, managing study coordination, evaluating potential participants for eligibility according to protocols, conveying non-medical trial information, and assisting in the informed consent process.

This role is accountable for the precise and prompt generation of source documents, data collection, documentation, entry, and reporting, including a timely response to inquiries from sponsors.

Additionally, the Clinical Research Associate I is responsible for compiling and presenting reports on each study, which includes details related to protocol activities, participant accrual data, workload, and other relevant research information during regular research staff meetings.

Key Responsibilities:

  • Independently coordinate studies, including screening potential participants for protocol eligibility, presenting non-medical trial concepts, and facilitating the informed consent process.
  • Schedule participants for research visits and procedures.
  • In collaboration with physicians and other medical staff, accurately document on Case Report Forms (CRFs) any changes in patient conditions, adverse events, concomitant medication usage, protocol adherence, and responses to study interventions.
  • Maintain accurate source documents related to all research activities.
  • Ensure timely and accurate data collection, documentation, entry, and reporting, including prompt responses to sponsor inquiries.
  • Schedule and engage in monitoring and auditing activities.
  • Compile and report on each study, presenting this information at regular research staff meetings.
  • Notify supervisors regarding any concerns related to data quality and study execution.
  • Collaborate closely with regulatory coordinators or directly with the Institutional Review Board (IRB) to submit reports on Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in compliance with local and federal regulations.
  • May undertake additional regulatory or IRB duties, budgeting responsibilities, and assist with patient research billing and reconciliation.
  • Ensure adherence to all federal and local regulations, including those set forth by the Food and Drug Administration (FDA) and local Institutional Review Board.
  • Uphold research practices in accordance with Good Clinical Practice (GCP) guidelines.
  • Maintain strict confidentiality of patient information in compliance with HIPAA regulations and applicable laws.
  • Participate in mandatory training and educational programs.

Qualifications:

Educational Background:
High School Diploma/GED required
Bachelor's Degree in Science, Sociology, or a related field preferred.

Licenses:
SOCRA or ACRP Certification preferred upon hire.

Experience:
Minimum of one (1) year of experience in clinical research is required.

About Cedars-Sinai:
Cedars-Sinai is a premier institution in delivering high-quality healthcare, encompassing primary care, specialized medicine, and research. Established in 1902, Cedars-Sinai has continuously adapted to meet the needs of a diverse population, setting benchmarks in quality patient care, research, education, and community service.

About the Team:
Cedars-Sinai stands as one of the largest nonprofit academic medical centers in the United States, with 886 licensed beds, 2,100 physicians, 2,800 nurses, and thousands of other healthcare professionals and staff.

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