Clinical Research Coordinator II

Clinical Research Coordinator (CRC) II is primarily responsible for screening, enrolling, and monitoring study participants to ensure protocol and regulatory requirements compliance. At Florida Research Institute (FRI), the CRC II will have an increased workload and overall responsibility for studies, as well as enhanced interaction with sponsors and Contract Research Organizations (CROs). This role involves representing FRI positively to the community, sponsors, CROs, study participants, and their family members.

• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol
• Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs
• Review laboratory results, ECGs, and other test results (e.g., MRI and Biopsy reports) for completeness and alert values, ensure investigator review in a timely fashion
• Recognize Adverse Events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator
• Schedule patients within visit windows
• Dispense study medication per protocol and or IVRS system. Educate subject on proper administration and importance of compliance
• Monitor subject progress on study medication

Documentation:

• Record data legibly, in real time on source documents
• Accurately record study medication inventory, medication dispensation, and patient compliance
• Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed
• Record protocol exemptions and deviations as appropriate with sponsor
• Maintain copies of patient-specific correspondence in source charts
• Assist regulatory personnel with completion of continuing/final review reports

• Excellent working knowledge of medical and research terminology
• Extensive working knowledge of federal regulations, Good Clinical Practices (GCP)
• Ability to communicate and work effectively with a diverse team of professionals
• Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word and Excel
• Excellent interpersonal skills, detailed-oriented and meticulous
• Ability to work independently in a fast-paced environment with minimal supervision

• 2+ years of clinical research experience

• GCP
• Research Professional Certificate – CCRC or exam eligibility preferred