CLINICAL RESEARCH ASSOCIATE
KEYRUS LIFE SCIENCE
- Monitoring of bioequivalence studies, for international pharmaceutical clients to ensure phase I CROs’ conformity with regulations, subject safety, and data integrity
- Monitoring of clinical sites (paper and eCRF), performing efficient collaboration with Investigators, Study Coordinators, and Regulatory Specialists
- Compliance with GCPs, SOP, FDA and EMA regulations
- Monitors and reports on progress of trial on assigned sites
- Ensures that all regulatory documents and approvals are in place prior to patients’ enrolment with all sites
- Ensures assigned sites to ensure that investigator and staff are qualified to conduct study and that facility and equipment are adequate
- Ensures that test article is properly handled, stored and dispensed as per protocol specifications
- Performs regulatory document review during study and ensures completeness of regulatory binder at site
- Performs review of accountability records of investigational product and ensures reconciliation of records at study close-out.
