Clinical Trial Associate 1

Xenon Pharmaceuticals•Needham, MA

1d•$74,000 - $91,900•Hybrid

About The Position

We are seeking a Clinical Trial Associate 1 or 2 to join our team. The Clinical Trial Associate 1 or 2 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 or 2 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 Director, Trial Operations, and will be based out of Boston, MA, USA in our Needham office. The level of the position will be commensurate with the candidate’s education and industry experience. This is a Hybrid position requiring a minimum of two onsite days per week.

Requirements

Bachelor’s degree in health sciences or related field
Clinical Trial Associate 1 requires 2+ years of relevant experience in pharma/biotech or CRO, or equivalent education and experience
Clinical Trial Associate 2 requires 4+ years of relevant experience in pharma/biotech or CRO, or equivalent education and experience
Ability to work on multiple clinical projects and manage priorities effectively
Knowledge of clinical trial processes and ICH-GCP guidelines
Ability to work both independently and as part of a multidisciplinary team
Excellent written communication, oral communication, and organizational skills are required
Proficient computer skills using Microsoft Word, Excel, PowerPoint, etc.
Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility

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.
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 file (eTMF) for sponsor documents, review of eTMF plans and perform quality oversight of CRO eTMF throughout trial.
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.
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 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 Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
Other duties as assigned.