In-House Clinical Research Associate II

Skip to main contentDashboardProfileJoin Talent NetworkSign InEnglishSingle PositionView All JobsIn-House Clinical Research Associate IIArden Hills US-MN, United States | US-MN-Arden Hills No longer accepting applications.Work ModeHybridRequisition ID631458Additional Location(s): US-MN-Arden HillsDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           About the role:Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.As an In-House Clinical Research Associate II, you will support the Global Clinical Operations (GCO) Center of Excellence by helping accelerate clinical study start-up, regulatory document readiness, and high-quality clinical trial execution across multiple studies and division portfolios. In partnership with divisional and regional clinical teams, you will coordinate activities that support efficient site activation, regulatory compliance, and investigator readiness while delivering exceptional service to clinical research sites.This role plays a critical part in advancing Boston Scientific's mission by supporting IRB and Ethics Committee submissions, informed consent customization, essential document collection, and clinical site readiness. You will collaborate with internal and external stakeholders to ensure clinical studies are initiated efficiently while maintaining compliance with applicable regulations, company policies, and service-level expectations.Work model, sponsorship, relocation:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.Your responsibilities will include:● Coordinate site regulatory submission activities and essential document collection for assigned clinical research sites across multiple studies and division portfolios.● Manage multiple site start-up activities and regulatory document workflows simultaneously while supporting study timelines and milestones.● Partner with clinical research sites to support informed consent form customization, negotiation, and related documentation.● Support IRB and Ethics Committee application submissions, approval tracking, and timeline management to achieve study start-up objectives.● Develop, prepare, complete, and track required regulatory, informed consent, and legal documentation.● Build collaborative relationships with clinical research sites and serve as a trusted resource throughout the site start-up process.● Document investigator and site readiness to support participation across multiple clinical studies.● Update and maintain study-specific start-up and closeout trackers, site metrics within Clinical Trial Management Systems, and documentation within electronic Trial Master File (eTMF) systems.● Provide regular updates to leadership regarding site start-up progress, investigator readiness, regulatory submissions, approvals, risks, and timelines.● Identify and escalate site start-up challenges while coordinating with principal investigators, site coordinators, clinical study leads, and other stakeholders to resolve issues.● Support enrollment, follow-up, and study closeout activities, as applicable.● Support internal quality audits and regulatory inspections while ensuring compliance with...