Clinical Research Coordinator II - Onsite
Company: Cedars-Sinai
Location: Fresno
Posted on: May 9, 2024
Job Description:
Job Description The Clinical Research Coordinator II works
independently providing study coordination including 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 information at regular research staff
meetings. May plan and coordinate strategies for increasing patient
enrollment, improving efficiency, training of personnel, or
identifying new research opportunities. Ensures compliance with all
federal and local agencies including the Food and Drug
Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and 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 and auditing
activities.
- 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.
- May coordinate training and education of other personnel.
- May participate in centralized activities such as auditing,
Standard Operating Procedure development, etc.
- May plan and coordinate strategies for increasing patient
enrollment, and/or improving clinical research efficiency. Primary
Duties and Responsibilities
- May identify quality and performance improvement opportunities
and collaborate with staff in the development of action plans to
improve quality.
- May identify new research opportunities and present to
investigators
- Participates in required training and education programs.
Qualifications Requirements:
- High School Diploma/GED required.
- 2 years Clinical research related experience required.
Preferred:
- Bachelor's Degree Science, Sociology or related degreeReq ID :
1958
Working Title : Clinical Research Coordinator II (Onsite)
Department : Cancer - SOCCI Clinical Research
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic/Research
Job Specialty : Research Studies/Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $28.30 - $48.11
Keywords: Cedars-Sinai, Hanford , Clinical Research Coordinator II - Onsite, Healthcare , Fresno, California
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