Why join Cardurion Pharma? We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease.  We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease.  We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease.  The Role: We are seeking a highly motivated, goal-oriented team player to join Cardurion’s Clinical Operations team as Sr. Clinical Trial Associate (Sr. CTA).  Reporting to the Senior Manager, Clinical Operations Oversight & Excellence, the Sr. CTA supports the operational planning and execution of one or more Global Phase 1-3 clinical studies. Working closely with the Clinical Trial Managers, the Sr. CTA coordinates study documents, vendor activities, maintaining study tracking, filing and quality reviews as well as supporting site start-up and monitoring activities.  The Sr. CTA will play a key role in working with cross-functional Cardurion team members, as well as team members from vendors and CROs in completing all required tasks to meet departmental and project goals.  This role is required to be onsite in Burlington office 3 days a week.  In a lean environment, this role requires a highly organized, proactive individual who can effectively manage competing priorities, demonstrate a roll-roll-up-your-sleeves mentality, and drive operational excellence across Clinical Operations.Here’s What You’ll Do: Support Clinical Trial Managers in the day-to-day operational management of one or more clinical studies including study start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirementsSupports the multidisciplinary clinical study team and collaborates with other functions as required for implementation and execution of the study(s)Contributes to the development of study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), study plans and tools, patient recruitment materials, CRF Completion Guidelines, as appropriate.Prepares study dashboards and metrics reports, as appropriate and independently supports providing key inputs to management for study oversight, operational decision making, and status updates.Assist in vendor oversight activities, such as tracking activities, collecting metrics and filing documents.Analyzes trends, identifies operational risks, and recommends mitigation strategiesManages CRO/Clinical Service Providers (CSPs) interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, Trial Master File)Leads and conducts routine reviews of key trial operational deliverables including, but not limited to monitoring report review, TMF status and completeness checks, organizing internal TMF QC processes and reconciliation activities, maintenance of study team training records.Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materialsOrganizes internal team meetings, supports planning of investigator meetings and other study-specific meetings as appropriateTrack study milestones, deliverables, and action items to support study timelines.Review of site activation document packagesLeads and coordinates the site budget and contract negotiations Identifies, assesses, and proactively resolves issues before escalation when appropriate.Mentor and onboard Clinical Trial Associates by providing training on departmental processes, systems, SOPs, study-specific procedures, and best practices; serve as an ongoing resource to support development and successful integration into the team.  Here’s What We’ll Bring to the Table:Highly competitive package with healthcare coverage including medical, dental and vision Fully funded Healthcare Savings Account for high-deductible PPO Plan4 weeks paid time off annually 10 company paid holidays and year-end shut down 401k (traditional and Roth offered) with company match A suite of Cardurion paid insurance coverage, including life insurance, short-term and long-term disabilityFlexible spending accounts for medical and dependent care expensesExpected Pay Range: $90,000-$100,000