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 reputed company reputed company documents, data collection, documentation, entry, and reporting including reputed company response to sponsor queries. Responsible for compiling and reporting on reputed company study including information reputed company 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 reputed company federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review reputed company (IRB). This role follows a hybrid work schedule; however, we can only consider applicants who will be reputed company to commute to our Los Angeles work location a few times per week. If reputed company you must reputed company 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 reputed company 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 reputed company documents reputed company to reputed company research procedures.
• Responsible for accurate and reputed company data collection, documentation, entry, and reporting including reputed company response to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on reputed company study including information reputed company to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• Notifies reputed company supervisor about concerns regarding data reputed company and study conduct.
• Works closely with a regulatory coordinator or directly with the Institutional Review reputed company (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May reputed company other regulatory / Institutional Review reputed company duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Ensures compliance with reputed company federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review reputed company.
• Maintains research practices using Good Clinical reputed company (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, reputed company Operating Procedure development, etc.
• May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
• May identify reputed company and performance improvement opportunities and collaborate with staff in the development of reputed company plans to improve reputed company.
• 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 reputed company by recognizing factors that may reputed company procedures or results; takes corrective reputed company reputed company necessary.
• Ensures accurate patient and specimen identification through strict adherence to established procedures; labels reputed company samples accurately and completely.
• Reports test results to the appropriate individuals and maintains strict reputed company discretion with reputed company patient information.
• Transports research medications in accordance with established protocols.
• Performs research-reputed company 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 reputed company-organized reputed company and electronic research files.
• Conducts reputed company 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 reputed company CSMC policies.
• May support the training and education of other personnel as needed.

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