Armando Neto Email & Phone Number

Brazil

Brazil

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines; Assesses the qualification of potential investigative sites, initiates and close clinical trials at investigative sites; Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely; Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues; Mentors junior level CRAs and serves as a resource for new employees; May be assigned clinical tasks where advanced negotiating skills are required; Functions independently with minimal oversight; May serve as subject matter expert on monitoring related activities; May be assigned to complex studies and/or sites; Provides leadership skills to assigned projects and within the Clinical Operations department.

Brazil

Brazil

Monitoring of investigational sites in order to protect subject safety and deliver high-quality data review and reporting in compliance to ICH-GCP, sponsor's SOPs and applicable regulations. Builds, manage and support strong site relationships, acting as a liaison between the sponsor and assigned sites, from selection to close-out visits.

Brazil

Review of source documentation, CRFs and regulatory files; Accountability of Investigational Products and clinical supplies; Ensure proper registry and report of adverse events according to protocol and applicable requirements; Provide training to site personnel on protocol and study SOPs; Prepare follow-up letters and reports; Data management; Creation of tools to assist and improve monitoring routine.

Brazil

Recruit, screen and enroll participants; Obtain participant’s informed consent; Schedule of tests and procedures; Dispensing of Investigational Products; Drawing, processing and shipment of biological samples; Ensure accuracy of documentation; Collection of documents for endpoint adjudication; Data report on electronic CRFs (InForm, Oracle, Merge, Adept); IRB communications.

Master'S Degree, Industrial Engineering

Quality Systems

Bachelor Of Pharmacy - Bpharm, Pharmacy