Clinical Trial Associate 1

4 weeks ago

Vancouver, Canada Xenon Pharmaceuticals Inc. Full time

Who We Are:
At Xenon Pharmaceuticals (NASDAQ:XENE), we are committed to providing a brighter future for patients suffering from neurological disorders. Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver innovative medicines for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

What We Do:
We are advancing an exciting pipeline of neurology-focused therapies, with a focus on commercializing novel treatments for epilepsy. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 Phase 3 program includes studies in adult patients with focal onset seizures and primary generalized tonic clonic seizures. In addition, XEN1101 is being evaluated as a treatment for major depressive disorder in both a company-sponsored Phase 2 clinical trial, as well as an investigator-led proof-of-concept study. Xenon's proprietary, pediatric formulation of ezogabine, XEN496, is being studied in a Phase 3 clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, where many innovative, early-stage research programs are underway. In addition to these proprietary programs, our pipeline includes clinical-stage partnered programs with valued collaborators. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.

About the Role:
We are seeking a Clinical Trial Associate 1 to join our team. The Clinical Trial Associate 1 will be an individual responsible for supporting Clinical Operations team members with project-specific support related to the conduct of clinical trials activities. The Clinical Trial Associate 1 will assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administrative and project tracking support.

This position reports to the Associate Director, Trial Operations and will be located in the Vancouver, BC, Canada location.

RESPONSIBILITIES:

- Work with the clinical operations team in review of clinical documents (Protocols, Informed Consents, study plans and related documents). Participate in study start up activities including preparation and maintenance of study reference manuals, site tools, templates, source documents and guidelines.
- Collaborate with CROs, vendors and clinical sites in performing the day-to-day activities of a clinical trial, including generating management status reports, tracking the collection, shipment, and analysis of all study samples and coordination of the distribution of clinical trial supplies, equipment, and laboratory kits.
- Assist with the review and tracking of key regulatory documents required for site activation, including the tracking and review of site/country specific informed consent forms.
- Develop and regularly update clinical trial tracking tools and systems that provide metrics and tracking of a clinical trial’s progress, including patient recruitment, trial supplies and trial documentation.
- Support the study specific trial master file by filing and maintaining electronic trial master fie (eTMF) for sponsor documents, review of eTMF plans and perform quality oversight of CRO eTMF throughout trial.
- Track and process approved invoices and authorized clinical trial payments to selected vendors and study sites.
- Attend study team and department meetings while assisting with meeting logistics (scheduling, room and equipment set up, attendance tracking), agenda preparation, meeting minutes, and collating materials for meetings.
- Compile shipment request to 3rd party laboratory vendors, track and ensure samples received at vendors, follow up with sites/CRO for missing samples, and prepare/provide summary reports to clinical trial manager as requested.
- Assist in monitoring of timelines, budgets, and clinical trial materials and supplies.
- Assist in the planning and preparation for Investigator meetings.
- Assist with document preparation for due diligence, audits and/or regulatory inspections.
- Complete quality control (QC) review of SOPs, protocols, informed consent, and other relevant study documents.
- Participate in special projects to continuously improve processes, tools and systems.
- Develop an understanding of clinical trial research through exposure to research protocols, the drug development process, clinical meetings, Company Standard Operating Procedures (SOPs), and Food and Drug Administration (FDA) guidelines as related to Good Clinical Practices (GCP).
- Act in accordance with Company policies, including, for example, the Code of Business Con

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