Clinical Research Coordinator II - Largo

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
• 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)
• 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
• Integrate 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
• Absorb and maintain copies of patient-specific correspondence in source charts
• Absorb and assist regulatory personnel with completion of continuing/final review reports

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
• Ability to communicate and work effectively with a diverse team of professionals
• 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 Digestive Health Specialists (FDHS), we are committed to inspiring hope and building a legacy. Founded in 2011, FDHS is the state's largest single-specialty, physician-owned gastroenterology practice. We provide unparalleled, compassionate gastroenterology care with a mission to offer the highest quality digestive health services while fostering advanced research to improve patient outcomes. Our team includes many "Top Doctors" recognized by Castle Connolly for their clinical excellence and dedication to the communities they serve. Join us at FDHS and make a difference in the lives of our patients and employees alike!