• Lead in Coordinating and site management of all aspects of clinical study from start-up to closeout, Supervise in- field clinicians, phlebotomist, pharmacists, nurse, technician, administrative staff, and data team.
• Set up study site for coordination, operation and management.
• Performs all aspects of the start-up process to include the development and approval of study specific documents, study schedules, and clinical planning.
• Clinical Operations
• Look into business development opportunities
• Conducted patient assessments and data collection according to study protocols
• Site management tasks
• Study coordination tasks
• Patient recruitment tasks
• Project management
• Research Administration
• Staffing, Staff Management and Training
• Data Integrity
• Regulatory compliance for all studies including coordination, submissions, and maintenance of regulatory files
• Set up SFRI SMO satellite program development in the region, including business development for the satellite sites.
• Patient Recruitment/Patient Scheduling and Consenting - Subject recruitment (Hands On), screening, enrollment and scheduling of research participants
• Set up and implement subject recruitment system- Connect SFRI database, PI data base, field recruitment team, sponsors recruitment resources

Preferred Qualities and Experience:

Extensive Experience in Clinical Operations

Has completed contract negotiations with sponsors

Regulatory Compliance & Documentation Knowledge

Staff Management & Training