Specialist, Clinical Research Monitoring, Northeast US

Edwards Lifesciences; Philadelphia (Philadelphia County); On-site; USD 85,000 - 120,000; Full time

Job summary

A leading company specializing in innovative medical devices seeks a Clinical Affairs professional to monitor clinical trials and ensure compliance with GCP. The successful candidate will utilize their expertise to assess data quality, train new staff, and contribute to clinical protocol development, all aimed at improving patient outcomes. With a commitment to employee growth and a supportive work environment, this role offers a competitive salary and benefits package.

Qualifications

• Minimum 3 years field monitoring or site-level study coordination experience.
• Experience in the medical device or regulated industry.
• Ability to travel up to 80%.

Responsibilities

• Field monitoring of studies and data collection for clinical trials.
• Provide oversight of trial activities and recommend process improvements.
• Develop and deliver training on GCPs and related regulatory documentation.

Skills

Problem-solving

Critical thinking

Strong understanding of cardiovascular anatomy

Technical writing

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.

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

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.