Role and Responsibilities:
-Staff management and proactive assessment of staffing needs to include hiring, training, and coaching/mentoring staff
-Provide mentorship and guidance to team members and cross-functional staff on study processes and study requirements
-Manage site workflow to ensure that patients/subjects, staff, and sponsors have the best customer service experience
-Oversight of study management including timely review of monitor reports and associated study deliverables
-Oversight of site study audits and inspections as needed
-Identify, assess, and work with the QA team to resolve site performance and quality/compliance issues
-Coordinate and manage various tasks in collaboration with the QA team & amp; Regulatory Manager to achieve site readiness for timely first patient first visit
-Obtain and maintain in-depth understanding of the study protocols and related procedures in order to contribute to the study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as needed/required
-Ensure site meets monthly screening, randomization, and completion/retention goals by assessing scheduling, troubleshooting, and maximizing staff availability
-Follow a quality process to ensure the site collects and enters high quality data and to reduce preventable deviations
-Ensure the site has high morale and works well as a team and meets our cultural goals and expectations
-Step into role as coordinator/research assistant as needed to assist the team
Financial Administrative:
-Maintain a tracking system of study related costs
-Generates monthly reports for each clinical trial, monthly financial reports for clinical research, and monthly reports for distribution of patient visits/meetings/enrolled patients for each physician.
-Works with finance/accounting department as needed for study costs and department budget
3-5 Must Have Skills/Qualifications:
- Internal IRB
- Updating DOA Logs
- Reporting/Auditing
