Senior Clinical Research Monitor

Edwards Lifesciences; Washington (District of Columbia); On-site; USD 106,000 - 140,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Research Monitor to join their Clinical Affairs team. In this pivotal role, you will ensure the safety and ethical conduct of clinical trials, working closely with medical professionals and regulatory bodies. Your expertise will help drive innovations in patient care, particularly in addressing complex heart valve diseases. This role offers a unique opportunity to impact patient outcomes positively while collaborating on groundbreaking technologies. If you are passionate about clinical research and want to contribute to life-changing solutions, this is the perfect opportunity for you.

Benefits

Competitive Salaries

Performance-Based Incentives

Diverse Benefits Programs

Qualifications

• 5+ years of clinical research monitoring experience with a focus on quality assurance.
• Proficient in data verification and regulatory compliance in clinical trials.

Responsibilities

• Monitor clinical trials for safety and compliance with protocols and regulations.
• Develop and deliver training on GCP and trial-related activities.

Skills

Clinical Research Monitoring

Quality Assurance

Regulatory Compliance

Data Verification

Communication Skills

Analytical Skills

Education

Bachelor's Degree in related field

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 Senior Clinical Research Monitor to join Edwards Transcatheter Mitral and Tricuspid Therapies team. As the Senior Clinical Research Monitor, you 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 Northeast region/Midwest 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.
• Develop and deliver 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. Act as a mentor to new or junior level employees.
• 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 Boards, Contract, and Training, developing process improvements.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
• 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.
• Edit/amend informed consent documents.

What you'll need (Required):

• Bachelor's Degree in related field or equivalent.
• 5 years of work experience in clinical research monitoring, with a strong focus on quality assurance, quality control, and regulatory compliance.
• Experience working in a 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):

• Proven experience in auditing clinical trials to ensure compliance with regulatory standards.
• Hands-on experience with database lock processes, including data verification and finalization.
• Experience with a variety of study phases (Phase I-IV) including complex trials, in pharmaceutical or medical device.
• Proficient in Monitoring Visits: Site Selection Visits (SSV), Initiation Visits (IV), Interim Monitoring Visits (IMV), Close-Out Visits (COV), Safety Follow-Up Visits, and Early Termination Visits, ensuring comprehensive oversight and adherence to study protocols.
• Knowledge of cardiovascular physiology and structural heart anatomy.
• Previous medical device Clinical Research experience in cardiology.
• Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification).
• Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k).
• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required.
• Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software.

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 Illinois (IL), the base pay range for this position is $106,000 to $140,000 (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.

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.