Coordinator III - Research Data

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

About the role

The Coordinator Research Data III is an experienced coordinator who demonstrates autonomy in the management of complex protocols, precepting and mentoring of new research staff, and assisting in quality review and process improvement. This position supports our organization's efforts to achieve service excellence to our patients, investigators, and sponsors.

Responsibilities

• Coordinate and manage complex protocols (multi-arm, multi-disciplinary, etc.), potentially as the sole coordinator on studies.
• Create and review source documents, collect and enter data, resolve queries, trigger financial payments, and manage study startup/closeout.
• Verify, organize, and record data in case report forms (CRFs), including CRF tracking, validation, updates, SAE reconciliation, and query resolution.
• Enter, validate, and audit clinical research data across electronic data capture systems.
• Assist with subject follow-up for clinical protocols and document/report clinical study progress to the assigned study team.
• Obtain reports and submit data forms, pathology, and radiology materials according to protocol requirements.
• Conduct protocol administration quality control monitoring, enforcement, and database maintenance coding.
• Act as liaison with the sponsor/CRO.
• Assist with the creation and implementation of tools to continuously improve team performance and communicate measurable improvements to management.
• Ensure adherence to team guidelines for timely preparation of study documents, data entry, and data locks.
• Precept and train research staff on new systems and programs applicable to study coordination, including coordination team, research nurses, infusion nurses, program managers, and regulatory affairs personnel.
• Track and report weekly workload and progress.
• Assist in the development and implementation of departmental operating procedures.
• Represent the coordination team in budget development-related meetings and assist in creating business development proposals by supplying coordination-related information and costs.
• Maintain communication flow regarding study budget agreements and budget amendments throughout the project term.
• Collect, organize, and review data, including the development of data points for IIT (Investigator-Initiated Trial) trials.
• Assist leadership with monthly quality checks of recorded data, verification of proper documentation, deviations, and compliance with timelines.
• Identify and document regulatory and protocol deviation findings, analyze findings, and communicate potential solutions to management.
• Verify proper reporting of events, including IRB reporting.
• Provide observations and feedback on IIT data at various study timepoints.
• Assist peers to ensure study deadlines are met (e.g., data entry, query resolution, source document creation, review of study startup materials).
• Perform other related duties as assigned.

Requirements

• Bachelor’s degree or 4 years of work-related experience in Health Science (required).
• Bachelor’s degree in Health Science (preferred).
• 4 years of progressively responsible research or data management experience (required).
• Experience in pharmaceutical-sponsored and investigator-initiated clinical research trials in the therapeutic area (preferred).
• Knowledge of ICH/GCP and FDA regulations for clinical trials (preferred).
• Excellent written and verbal communication skills (preferred).
• Proficiency in MS Word, Outlook, PowerPoint, Excel, and EDC (electronic data capture) (preferred).

Qualifications

• IATA Certification (preferred).
• Clinical Research Certification (preferred).