Clinical Quality and Data Integrity:
- Capable of performing all required procedures; performs procedures as needed.
- Trains staff in performing procedures consistent with PRA Work instructions and SOPs.
- Supervises assigned area of responsibility (clinic floor, screening, recruiting, etc.)
- Participates in and may lead maintenance, preparation, and training of clinical equipment and specialized study specific equipment
- Ensures that all observations and procedures are performed and documented accurately and in real time.
- Escalates issues and deviations immediately to Functional Manager and Principal Investigator, as needed.
- Ensures staff complete required study protocol training
- Proficiency in and supervises data entry and query resolution process, ensures timely query resolution.
- Facilitates change and upgrades to increase efficiency, effectiveness, and clinical quality in clinic operations.
- Ensures proper supply levels and orders supplies as necessary
- Ensures the integrity of all studies through observation of staff and quality control of documentation
Customer Service and Subject Safety:
- Manages a team for optimal performance.
- Ensures subject safety in the clinic.
- Accepts projects as needed to facilitate optimal clinic operations – done in a timely manner using current evidence and industry standards.
- Assists with preparation of action plans to resolve issues.
- Accepts responsibility for updating work instructions in a concise manner using current evidence and industry standards.
- Works with scheduling to ensure appropriate staffing.
- Approves time entry for staff in a timely manner.
- Supervises new staff in training program.
- Monitoring (other) clinic activities assigned to staff – Queries, Study Set-up, Clinic Maintenance and Organization.
- Monitors required on-line training requirements for staff – required SOPs, study specific training – and signature status of all site signature logs.
- Assists in the development and implementation of training and orientation
- Leads staff meetings, huddles, etc.