Additional Locations: US-NC-Charlotte

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

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 individual will support Southeast, Atlanta and Charlotte.

Your responsibilities will include:

Role: Site Manager

  • 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.

Role: Monitor

  • 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.

Role: Quality and Process Improvement Champion

  • 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

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Requisition ID: 475615

Nearest Major Market: Atlanta

Job Segment: Clinic, Medical, Research Associate, Clinical Research, Healthcare, Research