Coordinator II - Clinical Research Oncology

Primary City/State: Shea Medical Office Building - 10150 North 92nd Street Scottsdale, AZ 85258 Category: Research Operations Shift: Day Department: HRI-Clinical Research Coordination Located at Bob Bove-Neuro research Monday - Friday Job Summary The Coordinator-Clinical Research II manages day-to-day execution of clinical trials across the research institute. Position provides clinical data support for the conduct of clinical research at HonorHealth Research Institute. The position works closely with all Research Staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices. Essential Functions Responsible for clinical data management of complex protocols: recruitment, screening, obtaining informed consent, reviewing source documents, data collection, query resolution, triggering financial payments, study startup and closeout. Serves as liaison with sponsor. Collects, verifies, organizes, and records clinical information. Assists with subject follow-up and documents clinical study progress. Obtains reports and submits data forms and pathology & radiology materials per protocol. Conducts protocol administration quality control monitoring. May participate in site initiation, interim monitoring, and study closeout visits with sponsor and FDA audits. May handle and label samples and ship them per protocol. Facilitates ongoing setup and closing of clinical protocols. Assists with creation and implementation of tools to continuously monitor team performance. Communicates department’s measurable improvements and positive trends to management. Assists with team guideline adherence to timely preparation of study documents, data entry, and data locks. Precepts and trains on new systems and programs applicable to the coordination role. Assists with weekly tracking and reporting of team’s workload and progress. Helps develop and implement departmental operating procedures. Represents coordination team in a variety of meetings. May aid in crafting business development proposals by supplying coordination information and costs. Assists leadership with monthly quality checks of recorded and submitted data, verifying proper documentation, deviations, and compliance with deadlines. Helps identify and document regulatory and protocol deviation findings, including IRB reporting. Provides assistance to peers to ensure that study deadlines are met. Identifies data management project issues, alerts leadership, and makes recommendations. Maintains communication with supervisor regarding regulatory and safety issues and any concerns affecting Good Clinical Practices. Participates in precepting and training of staff on data management procedures and systems. Performs other related duties as assigned. Performs other duties as assigned. Education In Health Science or 4 years of health science-related experience Experience 2 years, of progressively responsible clinical / clinical research or data management experience Required Other, Experience in pharmaceutical-sponsored and investigator-initiated clinical research trials in the therapeutic area. Preferred Other, Knowledgeable of ICH/GCP, FDA regulations for clinical trials and strong project management skills. Preferred Other, Strong writing and computer skills, including MS Word, Excel, Access, EDC (electronic data capture). Preferred License and Certifications Basic Life Support (BLS) - Certification, Required Clinical Research Certification Preferred IATA Certification Preferred #J-18808-Ljbffr HonorHealth