Clinical Research Specialist

3 weeks ago

Irvine, United States Edwards Lifesciences Full time

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 an in-house Clinical Research Specialist to join Edwards. As the Clinical Research Specialist, you will be responsible for assisting and analyzing data from various sources to ensure compliance, accuracy, and efficiency in operations. This role involves monitoring performance metrics, identifying potential issues, and implementing corrective actions to maintain optimal operational standards. This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.How you'll make an impact: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.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.Monitor real-time data from various sources to ensure accuracy and compliance.Analyze performance metrics to identify trends, anomalies, and areas for improvement.Generate detailed reports on operational performance, compliance issues, and other key metrics.Present findings to relevant stakeholders, including management and team leaders.Identify and investigate discrepancies or irregularities in data.Coordinate with relevant departments to resolve issues promptly and effectively.Ensure all operations comply with company policies, industry standards, and regulatory requirements.Conduct regular audits to maintain high-quality standards.Recommend and implement process improvements to enhance operational efficiency and accuracy.Stay updated with industry trends and best practices to continually enhance monitoring strategies.Work closely with various departments, including IT, operations, and customer service, to ensure seamless operations.Participate in cross-functional projects and initiatives to support company goals.What you'll need (Required):Bachelor's Degree or equivalent in Life Sciences or Nursing3 years' experience in clinical research (site management, clinical project management, monitoring, and/or CRC) including quality assurance/control and regulatory compliance or field monitoring with experience in the healthcare industryExperience in electronic data captureAbility to travel up to 25%Covid VaccinationWhat else we look for (Preferred):Bachelor's Degree in Computer Science, Statistics, Information Systems.Previous Centralized Monitoring work experience.Experience with Cardiovascular device trials or structural heart clinical research knowledgeProven experience in a monitoring or analytical role, preferably within clinical research.Strong analytical skills with the ability to interpret complex data sets.Proven expertise in data analysis tools and software (e.g., Excel, SQL, BI tools) including MS Office Suite.Excellent attention to detail and problem-solving abilities.Strong communication skills, both written and verbal.Ability to work independently and as part of a team.Knowledge of industry standards and regulatory requirements is a plus.Experience with real-time monitoring systems.Certification in data analysis or quality assurance.Ability to manage competing priorities in a fast-paced environmentAbility to interact professionally with all organizational levelsAligning 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 California, the base pay range for this position is $83,000 to $117,000 (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 RequirementEdwards 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.

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