Science 37

Clinical Research

• Recruit, enroll, and conduct follow-up of study participants in clinical trials under Principal Investigator and Project Manager supervision
• Coordinate trial participation according to protocols, SOPs, GCP/ICH guidelines, FDA regulations, and applicable regulations
• Implement and execute clinical trial activities from study start-up through closure
• Attend and lead investigator, project, and department meetings and trainings as needed
• Serve as temporary Project Manager for smaller studies when needed
• Determine participant eligibility with study investigators
• Screen participants, present trial details, participate in informed consent, and enroll participants
• Support development, review, and distribution of clinical protocols, consent forms, study instructions, and related documents
• Coordinate patient care and medication-administration education; maintain investigational drug accountability
• Review participant condition changes, adverse events, concomitant medications, protocol compliance, and response to study drug; document findings
• Collect, document, enter, and report data accurately and timely
• Schedule and participate in monitoring and auditing activities
• Maintain knowledge of assigned protocols and ensure compliance with Sponsor, FDA, and IRB requirements
• Maintain consent forms, case report forms, SAEs, source documents, and regulatory files
• Coordinate clinical research logistics and project objectives
• Participate in training and educate personnel and vendors
• Collaborate with Project Managers on trial procedures and vendor management
• Provide process-improvement solutions and support implementation
• Maintain participant confidentiality and a safe research environment in compliance with HIPAA and applicable regulations
• Mentor and support other Clinical Research Coordinators
• For hybrid trials: act as site/Sponsor point of contact, develop project and communication plans, and collaborate with study and multidisciplinary teams