Clinical Research Coordinator I - Department of Neurology (Hybrid)
Cedars-Sinai · Los Angeles, CA · 4 days ago
AnalystFull-time
About the role
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.
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.
- 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.
- Collaborates with other personnel to coordinate training and education.
Department-Specific Duties and Responsibilities
- Transportation of research medications.
- Performs research study related assessments and questionnaires.
- Affords assistance 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.
- Affords assistance with preparing manuscripts, letters, and other research documents as needed.
- Responds to sponsor’s 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.