Sr. Clinical Trial Associate (Hybrid - Acton, MA)

Job Summary The Clinical Trial Associate (CTA) is a core member of the Clinical Affairs team and is responsible for independently supporting the planning, execution, and closeout of domestic and international medical device clinical trials. This role operates with a high degree of autonomy and serves as a key operational liaison between Clinical Project Management, Regulatory, Quality, vendors, and clinical sites. The CTA ensures clinical trial activities are conducted in compliance with applicable regulations (e.g., FDA, ISO 14155, ICH GCP), company SOPs, and study specific requirements. In addition to hands on trial execution, the CTA may contribute to process improvement initiatives, vendor oversight, inspection readiness, and departmental operational excellence. The differentiating factors between a CTA and Sr. CTA are a higher level at the senior level of autonomy, comprehension and application of GCPs, FDA regulations and guidelines, ICH guidelines, SOPs and work procedures, applicable medical indication experience and expertise, and ability to work across all parties associated with clinical trials (investigators, site staff, clinical trial staff, IRBs, legal bodies, regulatory bodies, DSMBs, etc.). Key Responsibilities Clinical Trial Execution & Operations Provide end to end operational support for clinical trials from study startup through closeout, including feasibility, site initiation, maintenance, and closeout activities. Independently maintain and track study timelines, milestones, enrollment metrics, and operational deliverables; escalating risks and issues proactively. Serve as a primary point of contact for clinical sites, CROs, and vendors for trial related operational matters. Support development, review, and execution of clinical trial documents including protocols, clinical monitoring plans, informed consent forms, and study manuals. Trial Master File (TMF) & Documentation Own the ongoing oversite, maintenance, quality, and completeness of the electronic Trial Master File (eTMF) in accordance with regulatory and internal requirements. Perform TMF quality checks, resolve discrepancies, and support TMF reconciliation and inspection readiness activities. Manage version control, review workflows, and distribution of finalized clinical documents in document control systems. Regulatory & Compliance Support Maintain study registrations and results reporting in ClinicalTrials.gov and applicable international registries. Support regulatory submissions, amendments, and responses in collaboration with Regulatory Affairs and Clinical Project Management. Ensure trial conduct aligns with applicable global regulations and standards, including FDA regulations, ISO 14155, and ICH GCP. Vendor, Budget & Financial Oversight Support clinical study budgets through review, tracking, and reconciliation of trial related costs. Initiate and manage purchase orders, track invoices, and support financial forecasting in collaboration with Clinical Operations and Finance. Support oversight of CROs and other vendors, including tracking deliverables and compliance with contractual obligations. Cross Functional Collaboration & Leadership Actively participate in cross functional clinical team meetings and contribute to decision making discussions. Track action items, maintain meeting documentation, and ensure follow through on assigned deliverables. Mentor or provide guidance to junior clinical team members as appropriate. Contribute to SOP development, process improvement initiatives, and implementation of clinical best practices. Other Senior CTA may independently lead smaller studies or geographic regions and provide day to day oversight to junior CTAs or CRCs. Support audit and inspection readiness activities, including internal audits, regulatory inspections, and sponsor audits. Perform other clinical operations duties as required to support departmental and organizational goals. Education and Experience Bachelor's degree in life sciences, healthcare, or a related discipline (or equivalent combination of education and experience). Minimum of 2-4 years (CRA) or 4+ years (Sr. CRA) of progressively responsible experience in clinical research or clinical operations within the medical device, pharmaceutical, or biotechnology industry. Demonstrated hands on experience supporting the execution of regulated clinical trials. Experience working with CROs, clinical vendors, and global clinical sites preferred. Skills and Competencies Strong working knowledge of clinical research regulations and guidelines (FDA, ISO 14155, ICH GCP). Excellent written, verbal, and interpersonal communication skills with the ability to interact effectively across functions and with external partners. Advanced organizational skills with the ability to manage multiple studies, priorities, and deadlines simultaneously. Strong attention to detail and commitment to maintaining high quality, i #J-18808-Ljbffr insulet