What are the responsibilities and job description for the Clinical Research Coordinator I - Department of Neurology (Hybrid) position at Cedars-Sinai Medical Center and Careers?
Job Description
Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world. Ranked among the best in the nation by U.S. News & World Report, our neurosurgeons and neurologists work together with experienced care teams to give patients the most effective treatment possible.
About the Role
This position will support the research programs in Department of Anesthesia and Neurology.
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.
Primary Duties and Responsibilities:
- Scheduling of research participants for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents thoroughly 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.
Department-Specific Duties and Responsibilities:
- 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.
Qualifications
Education:
- High School Diploma/GED, required.
- Bachelor's degree in a Science, Sociology, or related field is preferred.
Licenses/Certifications:
- ACRP/SOCRA certification is preferred.
Experience:
- 1 year of clinical research experience, required.