Job Description

Additional Location(s): US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At 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 ICH/GCP, MDR, GDPR, internal standard operating procedures, work instructions, policies, and applicable regulatory requirements.

Required qualifications:

● Bachelor's degree in a clinical, scientific, healthcare, life sciences, or related field, or an equivalent combination of education and relevant experience.

● Minimum of 3 years' experience in clinical or scientific research, including clinical study site start-up activities within the United States.

● In lieu of a bachelor's degree, minimum of 7 years' experience in clinical research, clinical study operations, site start-up, regulatory documentation, or related healthcare or life sciences experience

● Proven experience supporting regulatory document collection, IRB or Ethics Committee submission processes, informed consent documentation, and clinical trial site readiness activities.

●Demonstrated experience managing multiple studies, regulatory document workflows, and competing priorities in a fast-paced environment.

● Demonstrated experience communicating professionally with clinical research site personnel through phone, email, and other communication channels.

● Working knowledge of applicable clinical research regulations and standards, including ICH/GCP, MDR, GDPR, internal standard operating procedures, work instructions, policies, and procedures.

● Strong collaboration, organization, written communication, and project management skills desired.

● Ability to travel up to 10% as business needs require.

Preferred qualifications:

● Previous experience as a Research Coordinator, In-House Clinical Research Associate, Clinical Research Associate, or Study Start-Up Specialist.

● Medical device clinical research experience supporting study start-up, regulatory documentation, or site activation activities.

● Experience using Clinical Trial Management Systems, including Veeva, and electronic Trial Master File (eTMF) systems.

● Experience supporting participant enrollment, follow-up, and clinical study closeout activities.

● Experience maintaining study trackers, site metrics, regulatory documentation, and inspection- or audit-ready files.

● Demonstrated ability to communicate study start-up status, risks, and escalation needs to cross-functional clinical study teams and leadership.

● Previous or curren Veeva, or eTMF experience preferred.

Requisition ID: 631458

Minimum Salary: $ 71500

Maximum Salary: $ 135800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.