Job Description

Reporting to the Senior Director, Clinical Operations, the Clinical Trial Assistant provides support to the clinical operations team in the execution of all aspects of clinical trial and regulatory operations activities in accordance with International Council for Harmonisation (ICH): Guideline for Good Clinical Practice (GCP), applicable regulations, and 35Pharma Inc. standard operating procedures (SOP)/policies.

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Key responsibilities:

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• Provide general administrative support to the clinical operations team.
• Support the clinical operations project team in the day-to-day management of clinical trial activities such as: prepare and distribute meeting agendas, minutes, and presentations; maintain action items and decisions logs; track and escalate issues (as appropriate) in a timely manner, etc.
• Set-up, maintain, and ensure project team members training records are in order and up to date.
• Manage preparation and distribution of study supplies (i.e., investigator site files (ISF), study material), as necessary.
• Distribute information to internal team members and external stakeholders (contract research organizations (CROs), vendors, sites).
• Maintain various tracking and reporting tools and systems needed by the clinical operations team.
• Maintain the clinical operations investigators database.
• Participate in the site feasibility and site selection process.
• Collect, track, and file sites essential documents and other required clinical documents for filing in the electronic trial master file (eTMF) under the guidance of the TMF Specialist.
• Update site-specific ISF checklist during the course of the study.
• Communicate directly with the CROs, clinical research associates, sites and other internal team members to ensure all documents required for the eTMF are collected and filed in a timely manner.
• Contact clinical sites for specific requests (i.e., enrollment updates, missing documentation, etc.).
• Assist the Associate Project Managers and Clinical Project Managers in the review of clinical trial agreements and site budgets, create tracking tool to capture costs per procedures per site and site payments, and verify site payment requests against visits and procedures completed in the electronic case report form (eCRF).
• May perform remote monitoring activities (i.e., remote source data verification (SDV) and data queries resolution, remote ISF review and reconciliation with TMF, etc.).
• May support any clinical and regulatory operations activities as deemed necessary to ensure the clinical program success.

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Qualifications:

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• Minimum of bachelor’s degree in health sciences or related degree within life sciences or equivalent experience.
• Minimum of 2 years’ experience in a clinical trial assistant, project coordination, or in-house CRA role in a pharmaceutical or biotechnology company, or a CRO. Previous on-site clinical monitoring  experience an asset.
• Flexible, independent and self-motivated.
• Excellent oral and written communication skills (French and English). (This position involves daily collaboration with suppliers, teams and partners located outside of Quebec, requiring a strong knowledge of English by the candidate).
• Ability to prioritize, organize, plan, and successfully execute multiple tasks and priorities simultaneously.
• An unwavering commitment to the highest quality of work, research ethics and willingness to learn.
• Demonstrated proficiency in required software (Word, Excel, PowerPoint) and other clinical systems (i.e., EDC, eTMF, Quality Management System (QMS)) and computer skills.

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Contact:

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Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting  “35Pharma Posting CTA0808” in the subject line – we are looking forward to hearing from you!

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