Clinical Research Coordinator II

Duties And Responsibilities

• Maintain all aspects of multiple protocols
• Aid in site qualification visits, initiation visits, and follow-up monitoring visits for all protocols
• Coordinate patient visits, including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drugs, assisting PI and sub-investigators with physical exams, and scheduling follow-up visits
• Inform patients about study-specific protocol requirements, procedures, side effects, and risks of trials and investigational medications
• Communicate with contract research organizations, IRBs, sponsors, central lab facilities, and other vendors to manage daily trial needs
• Manage regulatory documents related to the ISF
• Follow Standard Operating Procedures (SOPs), policies, and procedures set by the company
• Support direct patient care procedures such as biopsies, surgeries, cosmetic procedures, and related tasks as per research protocols
• Handle prescription processing and prior authorization requests, addressing patient and/or pharmacy inquiries regarding medications
• Enroll patients in patient education/assistance programs
• Ensure timely completion of necessary study-related documentation and correspondence with study subjects, teams, vendors, and sponsors
• Lead SIV, IMV, COVs, and other sponsor-related meetings
• Practice safety, environmental, and infection control methods
• Process blood and urine samples in compliance with IATA and OSHA standards
• Assist with clinical research manager's tasks and delegate tasks to CRAs and CRC Is as assigned
• Perform routine data verification and quality control to ensure data integrity and consistency with study protocol
• Possess in-depth knowledge of all current/active protocols
• Perform other duties that benefit the organization

Qualifications

• Advanced knowledge of clinical research regulatory procedures and study protocol priorities
• Exceptional organizational skills and ability to manage multiple high-priority tasks concurrently
• Consistent commitment to high-quality and timely study execution
• Experience in managing multiple protocols and conducting patient visits
• Ability to communicate effectively with various stakeholders including contract research organizations, IRBs, sponsors, and vendors
• Knowledge of regulatory documents and adherence to Good Clinical Practice (GCP), ALCOA-C principles, and institutional standards (USDP)
• Proficiency in using electronic data capture (EDC) systems and maintaining accurate records
• Strong interpersonal skills and ability to serve as a role model for professionalism and best practices
• Experience in direct patient care procedures and handling medical tasks related to research protocols
• Knowledge of safety, environmental, and infection control methods
• Ability to process prescriptions and handle prior authorizations
• Experience in enrolling patients in patient education/assistance programs
• Understanding of clinical research regulatory procedures and study protocol priorities
• Experience leading meetings and delegating tasks to team members
• Experience in performing routine data verification and quality control