Clinical Research Coordinator I - Heart Institute - Makkar Team

Cedars-Sinai Medical Center•Los Angeles, CA

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 research source documents, data collection, documentation, entry, and reporting, including responding to sponsor queries. The coordinator compiles and reports study information, including protocol activity, accrual data, workload, and other research information, and presents it at regular research staff meetings. The position ensures compliance with federal and local agency requirements, including Food and Drug Administration (FDA) and Institutional Review Board (IRB) requirements, and maintains research practices according to Good Clinical Practice (GCP) guidelines. It also requires maintaining patient confidentiality in accordance with HIPAA and applicable law. The role may include regulatory and IRB duties, budgeting, and assistance with patient research billing and reconciliation.

Requirements

High school diploma.
One year of clinical research-related experience.
Ability to interpret and apply 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.
Clinical Research certification from SOCRA or ACRP.

Responsibilities

Coordinate studies independently, 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.
Work 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 (CRFs).
Maintain accurate source documents related to research procedures.
Collect, document, enter, and report study data accurately and on time, including responding to sponsor queries in a timely manner.
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 or study conduct.
Work with a regulatory coordinator or directly with the IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters according to local and federal guidelines.
May perform other regulatory or IRB duties, budgeting duties, and assist with patient research billing and reconciliation.
Ensure compliance with federal and local agency requirements, including FDA and IRB requirements.
Maintain research practices using GCP guidelines and protect patient confidentiality according to HIPAA and applicable law.
Participate in required training and education programs.