Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. The Global Clinical Affairs function provides leadership and direction on all clinical decisions related to the overall Leica Biosystems business strategy.The Clinical Research Associate holds an essential position within clinical operations function of the Global Clinical Affairs team to ensure adherence to Good Clinical Practice (GCP) and department standard operating procedures. This position will be fully remote and report to the Director of Clinical Operations, responsible for the effective implementation and execution of our clinical trials and research initiatives. If you thrive in a collaborative and fast paced environment and want to work to build a world-class diagnostics organization—read on.In this role, you will have the opportunity to:
Conduct overall site management of clinical studies for product verification and/or validation.
Represent the Global Clinical Affairs team working closely with external stakeholders to ensure project requirements are met and clinical trials are conducted successfully and compliantly.
Complete activities related to the set-up, initiation, execution, and close-out of device related clinical trials according to applicable regulations and Good Clinical Practice (GCP).
Conduct timely monitoring of clinical data collected via on-site and remote monitoring visits, including reviewing and reconciling data and documentation related to Protocol Deviations and Adverse Events.
Develop and maintain ongoing relationships with investigators/institutions/vendors to ensure quality and on time delivery of related clinical programs.
The essential requirements of the job include:
BA/BS or e quivalent combination of education and experience
2+ years experience within clinical research industry
Travel up to 50% expected
It would be a plus if you also possess previous experience in:
GCP Trained
Basic knowledge of regulatory requirements for in vitro diagnostic and medical device products
At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.The salary range for this role is $80K-$95K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.This job is also eligible for bonus/incentive pay.We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.