Coordinator II - Clinical Research Bariatric GI

Shea Medical Office Building - 10150 North 92nd Street, Scottsdale, AZ 85258

About the Role

The Coordinator-Clinical Research II manages day-to-day execution of clinical trials across the research institute. This position provides clinical data support for the conduct of clinical research at HonorHealth Research Institute and 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.

Responsibilities

• Responsible for clinical data management of complex protocols, including recruitment, screening, obtaining informed consent, reviewing source documents, data collection, query resolution, triggering financial payments, and study startup/close out.
• Serves as a liaison with sponsors.
• Collects, verifies, organizes, completes, and records clinical information.
• Assists with subject follow-up for clinical protocols and documents/reports clinical study progress as required.
• Obtains all reports and submits data forms, 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 sponsors and FDA-initiated audits as needed.
• May be required to handle, label, and ship samples according to protocol requirements.
• Facilitates ongoing setup and closing of clinical protocols.
• Assists with the creation and implementation of tools to continuously monitor team performance.
• Communicates departmental 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 staff on new systems and programs applicable to the coordination role.
• Assists with weekly tracking and reporting of the team’s workload and progress.
• Assists in the development and implementation of departmental operating procedures.
• Represents the 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 the conduct of monthly quality checks of recorded and submitted data, including verification of proper documentation, 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 peers to ensure study deadlines are met.
• Identifies data management project issues, alerts leadership, and makes recommendations.
• Maintains communication with supervisors 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.

Requirements

• Education in Health Science or 4 years of health science-related experience.
• 2 years of progressively responsible clinical/clinical research or data management experience.
• Experience in pharmaceutical-sponsored and investigator-initiated clinical research trials in the therapeutic area (preferred).
• Knowledgeable of ICH/GCP, FDA regulations for clinical trials, and strong project management skills (preferred).
• Strong writing and computer skills, including MS Word, Excel, Access, and EDC (electronic data capture) (preferred).

Qualifications

• Basic Life Support (BLS) Certification (required).
• Clinical Research Certification (preferred).
• IATA Certification (preferred).

Schedule

Monday - Friday, Day shift