Senior Clinical Research Associate

Additional Location(s):  N/A

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 this role:

This role requires coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the Senior Clinical Research Associate conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. The Senior Clinical Research Associate also provides support in enrollment, follow-up, and closure of clinical trial activities.

 

This is a hybrid position (in office minimum three days per week) to be located in San Jose, CA. 

 

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 Form (ICF)
• 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 agreement 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, regulatory inspections, as applicable.
• Update and maintain study-specific startup 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, regulatory submission, approval status, etc.
• Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate.
• Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures.

 

Required qualifications:

• Minimum Bachelor’s Degree, or an equivalent combination of experience and education.
• Minimum 2 years’ experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within the US
• Ability to multi-task: support several studies and comfortable interacting with clinical research site personnel

 
Preferred qualifications:

• Proven research Coordinator or Study Start up specialist experience.
• Prior or current experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF
   

Requisition ID: 594240

The expected annualized base pay range this full-time position working at this location will be from $91,500 to $173,800 plus annual bonus (subject to plan eligibility and other requirements) and the value of core and optional employee benefits being offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. At BSC, it is not typical for an individual to be hired near the bottom or top of the pay range. Boston Scientific considers various factors in determining actual compensation for this position at the expected location. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs. Actual compensation may be otherwise adjusted if the position is filled outside of the intended geographic location.

 

Among other requirements, Boston Scientific mainta