Coordinator II - Clinical Research Bariatric GI

Responsibilities: 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. May be involved in many of the following activities: recruitment, screening, obtaining informed consent, reviewing source documents, data collection, query resolution, triggering financial payments, study startup/close out. Serves as a liaison with sponsor. Collects, verifies, organizes, completes and records clinical information. Assists with subject follow-up for clinical protocols and documents/report clinical study progress as required. Obtains all reports and submits data forms and pathology and radiology materials according to protocol requirements. Conducts protocol administration quality control monitoring. May participate in site initiation, interim monitoring, and study close out visits with sponsor and FDA initiated audits as needed. May be required to handle and label samples and ship samples according to protocol requirements. Facilitates ongoing set up and closing of clinical protocols. Assists with creation and implementation of tools to continuously monitor team performance. Communicates departments measurable improvements and positive trends to management. Assists with team guideline adherence to timely preparation of study documents, data entry, and data locks. Precepting and training on new systems and programs applicable to the coordination role. Assists with weekly tracking and reporting of team's workload and progress. Assists in development and implementation of departmental operating procedures. Represents coordination team in a variety of meetings. May assist in the creation of business development proposals by supplying coordination related information and costs. Assists leadership with conduct of monthly quality check of recorded and submitted data. This includes the verification of proper documentation of the data, deviations, and compliance with deadlines. Assists with the identification and documentation of regulatory and protocol deviation findings, including IRB reporting. Provides assistance as needed to peer to ensure that study deadlines are met. Identifies data management project issues and alerts leadership and makes recommendations. Maintains communication with supervisor regarding regulatory and safety issues as well as any concerns that reflect upon 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. Educationin 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. PreferredOther, Knowledgeable of ICH/GCP, FDA regulations for clinical trials and strong project management skills PreferredOther, 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 PreferredIATA Certification Preferred