Ref #: 32075

Employment type: Permanent - Full-Time

Location: Sao Paulo

Posted: 14-Sep-2021

Description

Job Functions:

• Clerical Review and assist in the process in accordance with SOPs incoming Serious AdverseEvent (SAE) forms, including site follow-up for resolution of data queries, assist in the distribution of IND Safety Letters to investigators and tracking of necessary Follow-up Report, as appropriate.
• Coordinates with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial. Assures currency of required clinical trial documents within Central Files(i.e., CVs, FDA 1572, Lab Certification, Financial Disclosure and normals, etc.) throughout the clinical trial.
• Maintenance of project specific regulatory documents inventory systems. Prepares investigator grant payment requests and corresponding cover letters for distribution to Sponsor´s Finance and Clinical Investigators.
• Maintains clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolves payment inquiries from investigator sites.
• Assists CPL/CRA in preparing and tracking investigational product (IP) supplies, packaging, and shipment requests and circulating these requests for appropriate approvals. Confirms site receipt of shipped IP, alerts responsible CPL whenever IP inventory requires review/re-order and assists with drug reconciliation.
• Assists in securing necessary administrative (non-drug) supplies for clinical trials and processes site requests for shipping supplies, as needed. Maintenance of clinical trial monitoring/management tracking systems.
• Other related duties as assigned.
• Work with US Clinical Project Team to assure the successful completion of a trial in the US.
• Assist with CRA/RCRA
• Set-up, populate and maintain the clinical trial monitoring/management tracking systems

Education Requirements

• Bachelor’s degree or coursing the last year of degree; preferably in health sciences.
• Minimum of 6 months site coordination, laboratory or medical experience (or equivalent).
• Pharmaceutical industry understanding process with previous exposure to medical terminology and GCPs.
• Familiarity with Windows-based computer applications (e.g., MS EXCEL and Powerpoint).
• Good interpersonal and communication skills.
• Detail-oriented and able to handle multiple tasks.
• MUST have a strong English level.

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