JOB SUMMARY

The Clinical Research Data Coordinator is responsible for the collection, coordination, processing, and quality control of all clinical trial data. They may assist with screening patients for research guidelines along with maintaining research protocol information, regulatory documents, and other research files as applicable. Works in compliance with Urology San Antonio Research Department (USARD), Standard Operating Procedure (SOP), principles of Good Clinical Practice, and all applicable federal, state, and local regulations.

DUTIES AND ESSENTIAL JOB FUNCTIONS

• Extrapolates data, completes case report forms, and ensures timely data submission in accordance with USARD SOP.
• Actively prepares/participate in monitoring and auditing activities. Assists in ensuring that all queries are resolved in a timely manner in accordance with USARD SOP and sponsor requirements.
• Responsible for processing, filing, and maintaining protocol regulatory documents.
• May assist with screening patients for potential study enrollment.
• Responsible for assisting with patient scheduling for procedures required to maintain protocol compliance.
• Responsible for assisting with coordinating patient follow-up visits and timely data submission.
• Responsible for assisting with the collection and processing of specimens, imaging documents, or other items required for research purposes.
• Responsible for ordering and maintaining research supplies.
• Responsible for assisting in the investigational drug accountability process.
• Maintains research records in a confidential manner according to practice policies, sponsor confidentiality agreements, HIPAA guidelines, and any other applicable regulations.
• May lead and mentor other data coordinators at the site/location
• May be responsible for coordinating patient billing and research payout/payment tracking.

Other functions and Responsibilities

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

COMPETENCIES

• Patient & Customer Focus
• Ethical Conduct
• Flexibility
• Initiative
• Personal Effectiveness/Credibility
• Stress Management/Composure
• EDC Platforms: RAVE, imedidata, Inform, Medrio

QUALIFICATIONS

Required

• Associates of Science Degree (or related field)
• Bachelor's Degree preferred