Job Description
The role is accountable for performance and compliance for assigned protocols and sites in acountry.Under the oversight of the CRA manager the person ensures compliance of study conduct withICH/GCP and country regulations, our policies and procedures, quality standards andadverse event reporting requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,taking overall responsibility of allocated sites.Actively develops and expands the territory for clinical research, finding and developing newsites.Participates in internal meetings and workstreams as SME for monitoring processes andsystems.
**Responsibilities include, but are not limited to**:- Develops strong site relationships and ensures continuity of site relationships through allphases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP,Sponsor SOPs, Local Laws & Regulations, Protocol, Site M...