Quality Coordinator

Description

The Quality Coordinator position will serve as a subject matter expert in the policies, procedures, and processes of our clinical research studies by verifying information is accurate on volunteer charts prior to their discharge. The position will work with clinical research team members to ensure that accurate information is collected, corrections are made in real time, and by providing training to prevent further errors from occurring. The Quality Coordinator position will serve as a resource for information for clinical research studies while ensuring compliance. This position reports to the Principal Clinical Data Manager.

Position Responsibilities

• Reviews study data captured in volunteer study binders to ensure compliance with protocols and other sponsor requirements for the duration of the trial while the volunteer is still on-site in real time
• Review study-related source documentation captured by the Clinic such as intake forms, visit worksheets, treatment histories, medical histories, clinical notes, laboratory results, ECG interpretations, medical records, adverse event reports, delegation logs, deviation logs, sponsor correspondence, sponsor-issued newsletters and memos, institutional review board documents
• Identify discrepant data capture and verify appropriate corrections are made for any incorrect, missing, or incomplete data through confident, knowledge-based conversations with the clinic team, study investigators, other appropriate study staff, and volunteers regarding corrections
• Provide education, as needed, for volunteers for diaries and ICFs prior to volunteer discharge
• Ensure visits are completed in Clinical Conductor ensuring volunteer payments are accurately allocated, ICFs are updated, and next visits are scheduled
• Source-data verify volunteer eligibility prior to their scheduled randomization or baseline visits
• Verifies volunteer safety and site adherence to FDA regulations, ALCOA-C, ICH/GCP guidelines and protocol-specific requirements
• Responsible for quality control and assurance and preparation for site monitoring visits, FDA audits, and sponsor audits
• Maintains accurate progress reports and other spreadsheets for tracking status of QA review and approval
• Contributes to and maintains QA department metrics and performance metrics for Clinical Operations staff
• Ensures correction and final approval of discrepancies noted in research data
• Identifies and assists in developing training programs for study staff and supporting departments based upon review metrics
• Provides real time training for clinic staff when errors are found in volunteer charts
• Collaborates with site investigators, clinical research coordinators, and other research staff to ensure all protocol guidelines have been completed appropriately
• Other duties as assigned
  
  

Requirements

• Subject matter expert with study protocols, ICF and sponsor provided documents
• Microsoft Office Suite and Clinical Conductor proficiency
• Excellent written, verbal and interpersonal communication skills
• Knowledge of medical terminology and concepts
• Proficient typing and data entry skills
• Ability to work effectively with a team
• Ability to manage small projects personally and work independently
• Memory to retain information and know where to research answers
• Time management skills
• Organizational skills
• Detail oriented with the ability to perform at a high level of accuracy
• Demonstrates strong analytical and problem-solving skills
• Self-motivated
• Must be results oriented, able to multi-task, and a quick learner
• Respond to the urgent needs of the team and show a strong track record of meeting deadlines