Job Title

Here we grow again!About Stiris ResearchStiris Research is an entrepreneurial Clinical Trial Management Company providing Phase I through IIIB full-service support to Biotechnology and Biopharmaceutical companies. We make a difference by collaborating in the life sciences to improve others' lives.Work model: Remote (Canada)Employment type: Full-timePosition SummaryStiris is seeking a highly organized and motivated Clinical Project Associate (CPA) to support the successful planning, execution, and delivery of clinical trials. Working closely with Clinical Project Managers (PMs), Clinical Research Associates (CRAs), and cross-functional teams. The CPA plays a key role in ensuring clinical trials are conducted on time, within scope, and in compliance with regulatory requirements.This is an excellent opportunity for someone looking to expand their career in clinical research.Key ResponsibilitiesClinical Project SupportProvide day-to-day operational support to Clinical Project Teams across multiple clinical trialsSupport trial start-up, maintenance, and close-out activities in alignment with clinical trial timelinesTrack clinical trial milestones, deliverables, and timelines; proactively flag risks or delaysCoordinate clinical trial teleconferences, including scheduling, agenda preparation, and meeting minutesTrial Master File (TMF) ManagementManage the TMF for assigned studies in compliance with International Conference on Harmonisation, (ICH) Good Clinical Practice (GCP), applicable regulations, and internal Standard Operating Procedures (SOPs)Prepare, review, and maintain essential study records (e.g., TMF artifacts, trackers, meeting minutes)Perform TMF quality checks and support ongoing inspection readinessAssist with audit and inspection preparation and follow-up activities Clinical Trial Records & TrackingDevelop and maintain clinical trial-specific forms, templates, trackers, and logs (e.g., contact lists, screening and enrollment trackers, monitoring visit trackers).Maintain clinical trial forms and templates repository to ensure accuracy and version controlCreate and maintain Clinical Trial Team Training Trackers and clinical trial-specific training recordsPrepare and maintain clinical trial plans, trackers, and status reportsSite & Clinical Trial CoordinationSupport investigator site identification and feasibility activitiesAssist with coordination and planning of Clinical Investigator Meetings (as applicable)Develop and coordinate the shipping of Investigator Site Files (ISF) and Pharmacy Binders (as applicable)Support Investigational Product and ancillary supply tracking and managementAdvanced / Growth ResponsibilitiesCoordinate and track investigator payments in collaboration with FinanceAssist with service provider management activitiesPre-RequisitesBachelors degree in life sciences, health sciences, or a related fieldKnowledge of applicable clinical research regulatory requirements, i.e., ICH guidelines GCPPreferred Competencies Strong computer skills including proficiency in use of Microsoft Word, Excel, and PowerPointStrong organization skills with high attention to detailAbility to manage multiple tasks and prioritize effectivelyExcellent written and verbal communication skillsDemonstrated reliability, professionalism, and eagerness to learnAbility to work collaboratively within a team and follow direction Comfortable with working remotely CompensationSalary range: CAD $50,000 - $60,000How to ApplyPlease submit your CV to Allyson MacLean ([email protected]) with the subject line: Clinical Project Associate, Clinical Operations.