Clinical Research Coordinator II – Head & Neck (Hybrid Role)

About the position 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). This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.

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.
• 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.
• Verifies specimen identification and assesses the appropriateness of test orders and specimen quality by recognizing factors that may affect procedures or results; takes corrective action when necessary.
• Ensures accurate patient and specimen identification through strict adherence to established procedures; labels all samples accurately and completely.
• Reports test results to the appropriate individuals and maintains strict professional discretion with all patient information.
• Transports research medications in accordance with established protocols.
• Performs research-related assessments and administers study questionnaires.
• Assists with prescreening of potential research participants for various clinical trials.
• Participates in research meetings and monthly sponsor conference calls for study updates.
• Maintains well-organized paper and electronic research files.
• Conducts all data collection and data entry activities for department clinical trials.
• Assists in preparing manuscripts, letters, and other research documents as needed.
• Responds to sponsor inquiries regarding protocol start-up and participant recruitment activities.
• Conducts literature reviews to support research activities.
• Assists with budget development and negotiation in collaboration with CTAO and study sponsors, ensuring full compliance with all CSMC policies.
• May support the training and education of other personnel as needed.

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