Specialist, Clinical Research Monitoring, Northeast US

Edwards Lifesciences; Boston (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Edwards Lifesciences, un leader dans la mise au point de dispositifs médicaux, recherche un coordinateur d'études cliniques. Le candidat idéal aura un diplôme, au moins 3 ans d'expérience en surveillance sur le terrain, et une solide compréhension des exigences réglementaires des dispositifs médicaux. Ce rôle implique la surveillance des essais cliniques, la formation des équipes et la vérification des données pour garantir la conformité.

Qualifications

• Minimum 3 ans d'expérience dans la surveillance sur le terrain ou la coordination d'études au niveau du site.
• Expérience dans l'industrie des dispositifs médicaux ou réglementée.
• Capacité à voyager jusqu'à 80%.

Responsibilities

• Surveiller les études et collecter des données pour les essais cliniques.
• Fournir des insights sur les activités d'essai et recommander des améliorations.
• Former sur les bonnes pratiques cliniques (GCP).

Skills

Problem-solving

Critical thinking

Technical writing

Data monitoring

Education

Bachelor's Degree

Tools

Electronic data capture

Job description

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommend and develop process improvements
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded
• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition
• Develop and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities
• Contribute to the development of clinical protocols, informed consent forms, and case report forms
• Edit/amend informed consent documents

You will need (Required):

• Bachelor's Degree
• A minimum of 3 years field monitoring experience or site-level study coordination experience
• Experience working in a medical device or regulated industry
• Experience with electronic data capture
• Ability to travel up to 80%

What else we look for (Preferred):

• Experience in heart failure and/or cardiology monitoring experience
• Problem-solving and critical thinking skills
• Strong understanding of cardiovascular anatomy, pathology and physiology
• Substantial understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Technical writing skills (protocols, CRF development, study tools)

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

The base pay range for this position is $85,000 to $120,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.