Clinical Research Coordinator

Overview

• Support the management and oversight of clinical trials, ensuring compliance with protocols and ethical standards.
• Collaborate with investigators, managers, and other departments to ensure smooth execution of research studies.
• Monitor study participants’ health and adherence to protocol guidelines throughout the trial.
• Coordinate lab work, imaging, and other required procedures for study participants.
• Document all aspects of study visits, including participant interactions and data collection.
• Maintain research records, including source documents, study logs, and case report forms.
• Ensure all necessary equipment is functional and supplies are adequately stocked.
• Educate study participants about study objectives and visit procedures.

Key Responsibilities & Duties

• Schedule, screen, and enroll subjects, obtaining informed consent and collecting medical history.
• Conduct study visits, monitor participant adherence, and manage adverse events or side effects.
• Coordinate with laboratories, imaging vendors, pharmacy staff, and infusion nurses.
• Assist with study submissions, protocol deviations, and reporting serious adverse events to IRB.
• Collect and enter data into source documents, study logs, EMR, and EDC systems.
• Direct specimen collection, labeling, packaging, transport, shipping, and storage.
• Ensure compliance with regulatory requirements and ethical standards.
• Order and organize lab kits and corresponding reports, maintaining medical records.

Job Requirements

• Bachelor's degree in a health-related field, preferably in science or medical studies.
• Minimum of 3 years of experience in clinical research, preferably in oncology.
• Phlebotomy license preferred, along with skills in vital signs, EKG, and lab kit management.
• Strong knowledge of medical terminology and clinical trial protocols.
• Proficiency in data entry and management systems, including EMR and EDC platforms.
• Ability to liaise with various departments and ensure protocol adherence.
• Excellent organizational skills to maintain research records and manage supplies.
• Strong communication skills to educate participants and coordinate with teams.