Clinical Research Coordinator I/CPT - Biobank Research Program - Department of Neurology - Per Diem (Hybrid)

Cedars-Sinai•Los Angeles, CA

2d•Hybrid

About The Position

The Clinical Research Coordinator I will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The CRC I member is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents study information at research staff meeting. This position ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.

Responsibilities

Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) information about changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
Schedules and participates in monitoring and auditing activities.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters following local and federal guidelines.
May perform other regulatory/Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
Coordinates training and education of other personnel.
Transportation of research medications.
Performs research study related assessments and questionnaires.
Assists with prescreening of research participants for various clinical trials.
Attends research meetings and monthly conference calls with sponsors for study updates.
Maintains organized paper and electronic research files.
Performs all data collection and data entry tasks for department clinical trials.
Assists with preparing manuscripts, letters, and other research documents as needed.
Responds to sponsor’ inquiries regarding protocol start-up activities and recruitment.
Performs literature reviews.