Clinical Research Associate

Additional Location(s): US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove

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:
The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world-class shared clinical technology, process innovation, and clinical operations team. This role partners closely with the company’s divisions through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.

 

Driving principles and behaviors for this role include caring, diversity, global collaboration, high performance, meaningful innovation, and a winning spirit.

 

Through coordination with the Contract & Budget team and collaboration with divisional and regional clinical teams, the CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents. These activities must be executed in accordance with service level agreements, legal and regulatory standards, and applicable company policies and procedures.

 

Key activities include:

• IRB submissions and approvals
• Site informed consent form (ICF) customizations and negotiations
• Essential regulatory document collection

 

The CRA also provides support in enrollment, follow-up, and closure of clinical trial activities.

 

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:

• Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.
• Manage multiple sets of essential regulatory documents across several studies and division portfolios.
• Partner with clinical sites to support the negotiation and customization of Informed Consent Forms (ICFs).
• Develop and foster clinical research site relationships to become a subject matter expert in the site start-up regulatory process across multiple studies.
• Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
• Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
• Manage and problem-solve site start-up challenges that arise to mitigate impact to service level agreements and study goals.
• Develop, prepare, complete, and track required regulatory, ICF, and legal documentation.
• Document clinical research site and investigator readiness for participation across multiple studies.
• Support internal quality audits and regulatory inspections, as applicable.
• Update and maintain study-specific start-up and close-out trackers.
• Update and maintain site-specific metrics in Clinical Trial Management Systems; file and maintain site documents in eTMFs.
• Provide updates to leadership on site start-up activities, investigator readiness, and regulatory submission/approval status.
• Escalate challenges and/or initiate outreach to principal investigators, clinical research site coordinators, divisional clinical study leads, and other stakeholders as appropriate.
• Ensure compliance with applicable regulatory requirements (e.g., ICH/GCP, MDR, GDPR) and internal SOPs/WIs, policies, and procedures.

 

Qualifications:

Required qualifications: