Clinical Research Coordinator I - Heart Institute - Makkar Team

Cedars-Sinai•Los Angeles, CA

1d•$25 - $41

About The Position

The Clinical Research Coordinator I works independently to coordinate clinical studies, screen potential patients for protocol eligibility, present non-medical trial concepts and details, and participate in the informed consent process. The role is responsible for accurate and timely source documentation, data collection, entry, documentation, and reporting, including responding to sponsor queries. The coordinator compiles and reports study information such as protocol activity, accrual data, workload, and other research details, and presents study information at regular research staff meetings. The position ensures compliance with federal and local requirements, including those of the Food and Drug Administration and the Institutional Review Board, and maintains research practices in accordance with Good Clinical Practice and patient confidentiality requirements.

Requirements

High School Diploma.
One year of clinical research-related experience.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations.
Ability to use discretion and maintain privacy, confidentiality, or anonymity.
Ability to convey and/or receive written and verbal information to and from various audiences in different formats.

Nice To Haves

Bachelor's degree in Science, Sociology, or a related field.
Certification in Clinical Research from SOCRA or ACRP certification.

Responsibilities

Independently coordinate studies, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in informed consent.
Schedule patients for research visits and procedures.
Collaborate with physicians and other medical personnel to document changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug on Case Report Forms.
Maintain accurate source documents related to research procedures.
Collect, document, enter, and report data accurately and on time, including responding promptly to sponsor queries.
Schedule and participate in monitoring and auditing activities.
Compile and report study information, including protocol activity, accrual data, workload, and other research information, and present it at regular research staff meetings.
Notify the direct supervisor of concerns about data quality and study conduct.
Work with a regulatory coordinator or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory or Institutional Review Board duties, budgeting duties, and assist with patient research billing and reconciliation.
Ensure compliance with federal and local agencies, including the Food and Drug Administration and local Institutional Review Board.
Maintain research practices using Good Clinical Practice guidelines.
Maintain patient confidentiality according to HIPAA regulations and applicable law.
Participate in required training and education programs.