Clinical Research Coordinator Ii

Clinical Research Coordinator II Overview

• The Clinical Research Coordinator II oversees clinical trials, ensuring smooth execution and compliance with protocols and ethical standards.
• Collaborate with multidisciplinary teams to support study start-up, enrollment, and closeout processes efficiently.
• Monitor study participants’ health and adherence to study protocols throughout the trial duration.
• Analyze and compile research data, summarizing findings for reporting and decision-making purposes.
• Maintain accurate and detailed research records, including case report forms and drug dispensation logs.
• Ensure availability and functionality of necessary equipment and supplies for trial operations.
• Direct specimen collection, labeling, storage, and transport in compliance with study protocols.
• Communicate effectively with study participants, administering questionnaires and addressing concerns.
• Support regulatory submissions and compliance with industry standards and guidelines.

Clinical Research Coordinator II Key Responsibilities & Duties

• Manage and oversee 3-4 clinical trials, ensuring adherence to protocols and timelines.
• Recruit, interview, screen, enroll, and randomize study subjects in compliance with study requirements.
• Collect and analyze research data, preparing comprehensive reports for stakeholders.
• Monitor participant health and adherence to study rules, administering questionnaires as needed.
• Maintain accurate source documentation and address protocol deviations promptly.
• Perform clinical procedures such as phlebotomy, vital signs monitoring, and ECG administration.
• Ensure regulatory compliance, including AE/SAE documentation and reporting.
• Coordinate stipend payments and manage study finances effectively.
• Order and maintain supplies necessary for clinical trial operations.

Clinical Research Coordinator II Job Requirements

• Bachelor’s degree in a health-related field preferred; Bachelor of Science (BS) required.
• Minimum of 2 years of on-site clinical research experience directly with patients.
• Proficiency in study start-up, enrollment, and closeout processes.
• Strong skills in regulatory filing, study submission, and addressing protocol deviations.
• Experience in phlebotomy, vital signs monitoring, and ECG administration.
• Ability to recruit, screen, and enroll subjects while obtaining informed consent.
• Competence in maintaining accurate source documentation and query resolution.
• Knowledge of stipend payment processes and study financial management.
• Strong organizational and communication skills to liaise effectively with participants and teams.