What are the responsibilities and job description for the Clinical Research Regional Manager 235518 position at Medix™?
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 & 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 as outlined in the Site's SOP's 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 the role as coordinator/research assistant as needed to assist the team
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
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