Clinical Research Coordinator II – Clinical Trials

About the role

This role follows a hybrid schedule, with 4 days onsite and 1 day remote. The schedule may require additional onsite presence based on patient needs, study activities, and operational priorities.

Responsibilities

• Provides study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, 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) 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.
• Compiles and reports on each study including information related to protocol activity, accrual data, workload, and other research information; presents 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.
• Performs other regulatory/IRB duties, budgeting duties, and assists 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 (IRB).
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient 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 increasing patient 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.
• Identifies new research opportunities and presents to investigators.
• Participates in required training and education programs.

Qualifications

• High School Diploma/GED – minimum
• Bachelor’s Degree in Science, Sociology or related degree – preferred
• 2 years clinical research related experience – minimum
• SOCRA or ACRP certification – preferred