Edwards Lifesciences
Senior Clinical Research Monitor, Midwest
Edwards Lifesciences, Chicago, Illinois, United States, 60290
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.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. 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 Aortic Field Monitoring team.
As a 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 the 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): 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
Additional skills: Demonstrated problem-solving and critical thinking skills
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
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As a 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 the 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): 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
Additional skills: Demonstrated problem-solving and critical thinking skills
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
#J-18808-Ljbffr