- 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