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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).

• 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.
• Participates in required training and education programs.

• Verify specimen identification, assess test order appropriateness, and evaluate specimen quality; recognize factors that may impact procedures or results and take corrective action as needed.
• Ensure accurate patient and specimen identification through strict adherence to established protocols; label samples accurately and completely.
• Report test results to appropriate parties while maintaining confidentiality and professional discretion.

• Coordinate transportation and handling of research medications.
• Perform study-related assessments and administer research questionnaires.
• Assist with prescreening potential participants for clinical trials.
• Attend research meetings and monthly sponsor conference calls to support study updates and execution.
• Maintain organized paper and electronic research files in compliance with regulatory standards.
• Perform data collection and accurate data entry for departmental clinical trials.
• Assist in preparing manuscripts, correspondence, and other research-related documents.
• Respond to sponsor inquiries regarding protocol start-up and recruitment activities.
• Conduct literature reviews to support ongoing and future research initiatives.

• Experience building, maintaining, and managing prospective clinical research databases (e.g., REDCap, OnCore, EMR extraction tools).
• Strong understanding of clinical data abstraction from medical records, including staging, treatment timelines, radiographic response, and survival endpoints in oncology.
• Knowledge of regulatory compliance standards (IRB, HIPAA, GCP) and commitment to data integrity and quality control.
• Experience with data cleaning, query resolution, and preparing datasets for statistical or translational analysis.
• Familiarity with longitudinal outcome tracking (e.g., ORR, mPR, PFS, OS, ctDNA kinetics).

• Experience coordinating biospecimen collection (blood, plasma, ctDNA, tissue) in oncology populations.
• Knowledge of specimen handling, labeling, processing, and storage in accordance with SOPs.
• Ability to collaborate effectively with patients, clinicians, and pathology teams to ensure timely specimen acquisition.
• Understanding of chain-of-custody procedures and biobanking workflows.
• Comfortable working in a multidisciplinary, high-volume clinical research setting.

• Basic to intermediate experience with immunohistochemistry (IHC), including slide preparation, staining protocols, and quality control.
• Familiarity with multiplex IHC and tumor microenvironment (TME) analysis preferred.
• Experience coordinating tissue sectioning and partnering with pathology core facilities.
• Understanding of biomarker-driven translational research (e.g., immune markers, stromal markers, KRAS-related pathways).

• Experience with computer-aided image analysis platforms (e.g., QuPath, HALO, ImageJ, or similar).
• Ability to quantify IHC staining intensity, spatial distribution, and immune cell infiltration.
• Basic statistical literacy, including correlation analysis and survival curve interpretation.
• Comfortable working with large, integrated datasets (clinical, molecular, imaging).
• Working knowledge of R, Python, or similar analytical tools preferred.

• Highly detail-oriented with strong organizational and project management skills.
• Ability to manage multiple concurrent studies in a fast-paced translational research environment.
• Strong communication skills with the ability to collaborate effectively across multidisciplinary teams.
• Self-directed, proactive, and capable of independent problem-solving.
• Demonstrated commitment to scientific rigor, patient-centered research, and translational impact.

Education

• High School Diploma or GED required
• Bachelor’s degree in Science, Sociology, or a related field preferred

EXPERIENCE

• Minimum of 1 year of clinical research–related experience preferred