Senior Specialist, Clinical Research Monitoring

Edwards Lifesciences; Massachusetts; On-site; USD 108,000 - 153,000; Full time

Benefits offered by this job

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences is seeking a Clinical Affairs professional to lead field monitoring and regulatory-compliance activities for clinical trials. You will work with investigators, medical professionals, and ethics boards to ensure data integrity and patient safety.

The role involves developing training on GCPs and trial procedures, overseeing protocol adherence, and contributing to protocol and consent form development.

Qualifications

• Bachelor's Degree or equivalent in related field with 5 years of field monitoring, quality assurance/control and regulatory compliance experience
• Ability to travel up to 75% domestically.

Responsibilities

• Field monitoring of studies and data collection for clinical trials, ensuring data consistency with study hypothesis and regulatory requirements.
• Developing and delivering technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, and study protocols; mentoring new staff.
• Providing oversight of trial activities and process improvements for sponsors and ethics boards; communicating findings to investigators and teams.
• Contributing to development of clinical protocols, informed consent forms, and case report forms.
• Validating investigational device accountability and maintaining regulatory documents; auditing site documentation.
• Editing or amending informed consent documents.

Skills

Communication skills

Presentation skills

Interpersonal skills

Analytical skills

Problem-solving

Critical thinking

Education

Bachelor's Degree or equivalent in related field

Tools

MS Office Suite (Word, Excel, PowerPoint)

Adobe

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.

We’re dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. We’re working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. 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, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
• Developing and delivering technical 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. Acting as a mentor to new or junior level employees.
• Providing 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 Boards, Contract, and Training, developing process improvements.
• Contributing to the development of clinical protocols, informed consent forms, and case report forms.
• Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
• Verifying 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.
• Editing/amending informed consent documents.

What you’ll need (Required):

• Bachelor's Degree or equivalent in related field with 5 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria.
• Ability to travel up to 75% domestically.

What else we look for (Preferred):

• Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification.
• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills.
• Demonstrated problem-solving and critical thinking skills.
• Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery.
• Excellent understanding of cardiovascular anatomy, pathology, and physiology or Business Unit area of expertise.
• Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting.
• Technical writing skills (protocols, CRF development, study tools).
• Ability to communicate and relate well with key opinion leaders and clinical personnel.
• Experience in training new hires.

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 $108,000 to $153,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.