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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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:

Specialist responsible for clinical research field monitoring and project team clinical research support throughout the full lifecycle of a clinical project.  Support of projects of a more complex nature and mentoring and training of junior level staff.

This role will support Michigan (Detroit) and the Mid-Atlantic (Baltimore). 

Your responsibilities will include:

• Ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan.
• Manages assigned clinical sites, partnering with field monitors and site staff to identify and escalate or resolve compliance issues, and escalation of site questions or needs.
• Participates in site start up activities as assigned.
• Routinely reviews site compliance data and works to identify compliance risks and issues.
• Partners with field staff to develop a CAP to address non-compliance issues as appropriate.
• Manages the completion of assigned project specific deliverables.
• Participate in site close-out activities for assigned clinical sites.
• Partners with colleagues to ensure assigned sites are audit ready at all times.
• Conducts a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites.
• Addresses non-compliance issues and trends at investigative site; develops, documents and implements a CAP as necessary.
• Conducts qualifications, initiation, interim and close out visits. Ensures all appropriate site staff are trained, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements.
• Participates as an extended team member of the clinical study team including: participating in study-specific meetings, teleconferences and investigator meetings.
• Conducts device accountability at clinical sites.
• Conducts study specific training for new study coordinators.
• Ensures that all adverse events are identified and clearly documented during visits.
• Serves as a mentor and trainer of junior Field CRA staff.
• Identifies and Reports complaints.
• Identifies and ensures communication of the need for corrective action at clinical sites. Collaborates with colleagues and clinical sites to develop and execute corrective action plans.
• Ensures training is completed per the required timelines and project needs.
• Identifies process improvement opportunities.  Independently proposes solutions/plans.
• Tracks internal process metrics data to measure performance.
   

What we’re looking for in you:

Minimum Qualifications

• Bachelor’s Degree in Science or Healthcare Related Field, or an equivalent combination of experience and education
• 3+ years of clinical research experience or monitoring experience, medical device experience, knowledge of applicable clinical research regulations (FDA, GCP, ISO)
• 2+ years monitoring experience OR primary research coordinator experience, for device and/or pharma studies
• Must be able to travel 50-75%'

Preferred Qualifications

• Rhythm Management/Electrophysiology/Interventional Cardiology device study experience 
• Experience with cardiac devices preferred 

Requisition ID: 475616

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.