Ref #: 34522

Employment type: Permanent - Full-Time

Location: Greater Montreal Area, Quebec

Posted: 07-Jan-2022

Description

A Clinical Project Assistant is responsible for site set-up and tracking activities (i.e regulatory documents, contracts and grants payments) including in-house management of documentation generated by the clinical sites

Qualifications:
• Clerical Review and assist in the process in accordance with SOPs incoming Serious Adverse Event (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 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 Clinical Project Team to assure the successful completion of a trial.
• Assist with CRA/RCRA
• Set-up, populate and maintain the clinical trial monitoring/management tracking systems

Requirements:
• CPA II: Bachelor’s degree plus minimum of 2 years 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.
• Detail oriented; Highly organized; Ability to handle multiple priorities efficiently; Reliable; Excellent telephone skills; Accurate; Excellent follow-up skills.
• Direct contact with sites and all levels of Clinical Development, US and France. Requires personal skills and knowledge of the business to be able to address all contacts efficiently and timely.
• Routine interaction with Regional Clinical Research Associates, Principal Investigators and site personnel to assure a smooth and consistent communication pathway.