Clinical Research Coordinator II
– Cancer Institute (Hybrid)
At Cedars-Sinai, we’re motivated by a collective spirit of innovation and the challenge to continuously improve.
Above all, we share a real passion for helping others.
This is just one of the many reasons U.S.
News & World Report has named us one of America’s Best Hospitals—and now we invite you to join us and make a difference every single day in service of this outstanding work – excellence and innovation in patient care, research, and community service.
From working with a team of committed professionals to using state-of-the-art facilities, you’ll have great resources to do something incredible—for yourself, and for others!
Join our team and help contribute to groundbreaking research!
The Clinical Research Coordinator II works independently providing study coordination including screening of prospective research participants 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 this information at research staff meetings.
- Scheduling of research participants for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research procedures.
- Schedules and participates in monitoring and auditing activities.
- Advises 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 initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May involve other regulatory / IRB duties, budgeting duties, and assisting with research participant billing and reconciliation.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local IRB).
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
- Coordinates training and education of other personnel.
- Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
- Plans and coordinates strategies for growing research participant enrollment, and/or improving clinical research efficiency.
- Identifies quality and performance improvement opportunities and collaborates 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.
Department and Unit Specific Job Responsibilities:
- Perform medical chart review of patients queried by the EIS team to confirm the diagnosis of various cancers.
- Enter clinical information of cancer patients (demographic, clinical, diagnosis, pathology, tumor stage, course of treatment, adverse event and outcomes) into various cancer databases.
- Link the clinical database with tissue and blood samples from pathology.
- Responsible for generating patient reports for basic, translational, or clinical research and grant writing.
- Work on IRB and regulatory aspects of the database and patient consent for the database if indicated and biorepository.
- Manages Databases for Translational Research Concierge (TRC) support group
- Identify clinics that are ideal for study recruitment and screen for patients that meet the inclusion criteria of the study.
- Consent patients and assist with streamlining the process.
- Assists with preparation of protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.
Assists with submission of continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
May respond to questions from the IRB or IACUC related to the regulatory aspects of the study.
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Education:
- High School Diploma/GED
– required - Bachelors of Science, Sociology, or related field
– preferred
Certification/License:
- ACRP/SoCRA (or equivalent) certification preferred.
Experience:
- Two (2) Years clinical research related experience
– required - Two (2) Years involvement in the coordination of clinical research trials
– required
Physical Requirements:
- Able to perform moderate lifting.
Able to sit, stand and walk for prolonged periods of time.
Able to read papers and online documents.
Able to operate standard office equipment.
Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.