Clinical Research Coordinator I - Kidney Transplant

Cedars-Sinai; Los Angeles (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Cedars-Sinai in Los Angeles is seeking a Clinical Research Coordinator I to work independently on study coordination, patient screening for protocol eligibility, and contributing to informed consent processes. You will ensure accurate source documents, data collection, entry and timely sponsor communications in a fast-paced transplant research setting.

Responsibilities include scheduling visits, documenting events on CRFs, coordinating monitoring visits, and maintaining HIPAA and GCP compliance

Qualifications

• High School Diploma or GED required.
• Bachelor's Degree in Science, Sociology or related field preferred.
• 1 year clinical research related experience required.

Responsibilities

• Coordinate studies independently, screen patients for eligibility, and participate in informed consent.
• Collect, document, and report study data and source documents in a timely manner.
• Schedule visits, monitor visits, site initiation visits, close-out visits, and audits.
• Communicate with sponsors regarding protocol clarifications and adverse events.
• Maintain compliance with FDA, IRB, HIPAA and GCP guidelines.

Education

High School Diploma/GED, required

Bachelor's Degree, Science, Sociology or related degree, preferred

Job description

Come join the Kidney Transplant Team!

The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Principal Responsibilities

Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.

• Schedules patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Schedules and participates in monitoring visits, aid in site initiation visits (SIVs), perform close-out visits (COVs), and auditing activities.
• Communicate with sponsors regarding exceptions and protocol clarifications.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• 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 in accordance with local and federal guidelines.
• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• 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

Job Description

Come join the Kidney Transplant Team!

The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

• Schedules patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Schedules and participates in monitoring visits, aid in site initiation visits (SIVs), perform close-out visits (COVs), and auditing activities.
• Communicate with sponsors regarding exceptions and protocol clarifications.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• 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 in accordance with local and federal guidelines.
• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• 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

• High School Diploma/GED, required
• Bachelor's Degree, Science, Sociology or related degree, preferred

Work Experience

• 1 Year Clinical Research Related Experience Required

Licenses and Certifications

• Certification In Clinical Research SOCRA or ACRP certification Upon Hire preferred