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

• 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. Primary Duties and Responsibilities
• 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.

• High School Diploma/GED required. Bachelors Degree preferred.
• 2 years Clinical research related experience required.

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