- 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.
- Other incidental duties
- Bachelor's Degree in related field or equivalent
- 5 years of medical device/sponsor/CRO/Pharma clinical field monitoring experience, quality assurance/control and regulatory compliance
- 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
- Knowledge of cardiovascular physiology and structural heart anatomy
- 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)
- Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
- Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
- 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
- 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
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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Senior Clinical Research Monitor, Midwest - Columbus, United States - Edwards Lifesciences
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.
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.As the Senior Clinical Research Monitor, you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.
You will make an impact by...
What you'll need (Required):
What else we look for (Preferred):
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.
As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.
If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination.In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.
Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work.From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
