Clinical Research Coordinator II

Duties

• Study Preparation
• Review and assess protocol (including amendments)
• Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff
• Aid in planning and creation of appropriate recruitment materials
• Aid in development of recruitment plan and obtain listing of potential candidates to contact from database
• Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
• Participate in Investigator’s meeting and/or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives
• Create (or review sponsor provided) protocol specific source documents
• Determine facility, equipment and outsource vendor availability
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
• Ensure education of staff and/or sub-investigators is completed for required tasks
• Study Management
• Integrate new trial load with existing trial load and prioritize activities with regard to protocol timelines
• Maintain organized files for blank source documents, patient charts, CRFs and supplies
• EDC entry of required visits within 72 hours of visit elements being completed
• Investigational product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient records
• Incorporate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings
• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of FRI team in an ongoing fashion
• Patient Coordination
• Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
• Contact scheduled Screening patients 72 hours prior to Screening appointment to verify pre-screened information has not changed
• Obtain informed consent per FRI SOP and document process. When revised ICF is received and discussed with patients during the trial adequate documentation required
• Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol and lab manual
• Review laboratory results, ECGs, and other test results (e.g., biopsy results) 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, Sponsor, and site regulatory coordinator
• Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
• Schedule patients within visit windows (including any outside procedures-MRI, biopsy, etc.), notify personnel as needed for procedures, and integrate visits with existing schedule to maximize efficient workflow and patient turnaround
• Dispense study medication per protocol and or IVRS system
• Educate patient on proper administration and importance of compliance
• Monitor patient progress on study medication
• Documentation
• Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress
• Correct errors per SOP
• Accurately record study medication inventory, medication, dispensation, and patient compliance
• Ensure accurate maintenance of dispensing logs and IVRS confirmations are conducted in a timely fashion
• Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
• Accurately transcribe data to CRFs
• Resolve data management queries and correct source data as needed
• Record protocol exemptions and deviations as appropriate with sponsor - Complete Memo to File for patients’ charts and regulatory filing if necessary
• Maintain copies of patient-specific correspondence in source charts
• Absorb and perform other duties as assigned

Knowledge, Skills, and Abilities

• Good working knowledge of medical and research terminology
• Enhanced working knowledge of federal regulations, good clinical practices (GCP)
• Ability to mentor and guide less experienced CRCs as they develop and gain experience
• Excellent organizational, prioritization and leadership skills and capabilities
• Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word, and Excel
• Excellent interpersonal skills, detailed-oriented and meticulous
• Excellent professional writing and communication skills
• Ability to work independently in a fast-paced environment with minimal supervision
• Experience: Three years clinical research experience Three years Clinical Research Coordinator experience A minimum of one year as a FRI Clinical Research Coordinator I or completion of FRI CRC competency form
• Licenses/Certifications: RN or LPN preferred Research Professional Certificate- CCRC or exam eligibility preferred

Culture

At Florida Research Institute, a division of Florida Digestive Health Specialist, LLP, we inspire hope and build your legacy. We are dedicated to fostering a culture where our patients are at the heart of everything we do. Join us and make a difference in the lives of our patients and employees alike!