Clinical Research Monitor

Edwards Lifesciences; Washington (District of Columbia); On-site; USD 89,000 - 125,000; Full time

Job summary

An established industry player is seeking a Clinical Research Monitor to join their innovative team. In this role, you will play a crucial part in ensuring the safety and compliance of clinical trials, working closely with medical professionals and regulatory bodies. Your expertise will help drive improvements in patient outcomes through rigorous data monitoring and oversight. This position offers the opportunity to contribute to groundbreaking technologies in the medical field while working in a dynamic and supportive environment. If you are passionate about clinical research and making a difference in patients' lives, this role is perfect for you.

Benefits

Competitive salaries

Performance-based incentives

Diverse benefits programs

Qualifications

• 3 years of clinical research experience including regulatory compliance.
• Strong understanding of cardiovascular anatomy and clinical trials.

Responsibilities

• Monitor clinical trials for compliance with protocols and safety.
• Provide oversight and insights into trial activities and data quality.
• Develop and deliver training on GCPs and regulatory documentation.

Skills

Clinical Research

Data Analysis

Regulatory Compliance

Communication Skills

Problem-Solving Skills

Analytical Skills

Education

Bachelor's Degree in Life Sciences

Nursing Degree

Tools

Electronic Data Capture

MS Office Suite

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.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

We are searching for a Clinical Research Monitor to join Edwards Transcatheter Mitral and Tricuspid Therapies team. As the Clinical Research Monitor, you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. The ideal candidate will reside in the Midwest/Northeast region.

How you'll 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.
• Other incidental duties.

What you'll need (Required):

• Bachelor's Degree or equivalent in Life Sciences or Nursing
• 3 years' relative work experience in the areas of clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance or field monitoring
• Experience working in a medical device or regulated industry
• Experience with electronic data capture
• Ability to travel up to 75% for clinical site visits
• Covid Vaccination

What else we look for (Preferred):

• 6 months to 1 year of clinical research field monitoring experience
• Clinical cardiac experience: proven expertise in roles such as EMT, Nursing, or Medical Assisting with a specialized focus on cardiac care, integrated with clinical research coordination experience to ensure comprehensive oversight and management of cardiovascular trials
• Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills
• Understanding of cardiovascular anatomy, pathology and physiology
• Experience with Cardiovascular device trials or structural heart clinical research knowledge
• Proven expertise in MS Office Suite and clinical systems, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
• Demonstrated problem-solving and critical thinking skills
• Substantial 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

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.

For New York City (NY), the base pay range for this position is $89,000 to $125,000 (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.