Danaher Corporation Senior Clinical Research Associate in Vista, California
Mammotome associates know that every moment matters when it comes to cancer diagnostics. When we come to work, we’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. Learn more about Mammotome at www.Mammotome.com.
Join our team as a Senior Clinical Research Associate and support products you can feel passionate about!
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.
Some the responsibilities we will trust you with:
This position is responsible for leveraging the Danaher Business System and tools in the timely and high-quality execution of clinical studies for pre-market and post-market programs. The role involves working independently with relevant departments (R&D, Regulatory Affairs, Product Support, Program Management, Marketing), and as directed by the Clinical Program Lead, to aid in design and preparation of clinical and analytical performance study plans, protocols, and reports, and associated study data collection forms. The Sr CRA:
Uses department processes and project management tools to independently complete all activities related to the set-up, initiation, execution and close-out of device clinical trials within defined study timelines, including: site selection/qualification, study site/vendor contracting, ethical approvals, site activation, data collection, timely review and analysis of data generated, interim monitoring/query resolution, and closure activities.
Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
Provides technical support and training to clinical investigators and their staff regarding device trial information, the protocol, subject enrollment, clinical and regulatory requirements and device implant support.
Leads communications with clinical investigators and their staff regarding activities in all phases of the trials to ensure study quality and timely deliverables.
Conducts assessments of complications and serious adverse events, including reviewing and reconciling data and documentation related to the event.
Conducts quality control to ensure compliance to the study protocol, trial material storage and accountability.
Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database.
Remains current with regulatory requirements for in vitro diagnostic and medical device products.
Provides up-to-date clinical study progress reports to Clinical Program Lead and/or teams as requested.
Your areas of knowledge and expertise that matter most for this role:
Bachelor’s or Master’s degree and over five years related clinical operations experience, preferably in in vitro diagnostic or medical device studies
Knowledge of regulatory requirements for in vitro diagnostic and medical device products
Laboratory experience is desirable
Excellent communication skills, both verbal and written
Excellent interpersonal skills, including negotiation skills
Excellent organizational skills and willingness to continuously improve together with the business
Ability to apply critical thinking skills in solving complex problems
Ability to work on multiple projects simultaneously
Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications
30% -40% travel required
This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.
Check out our benefits here: https://danaherbenefitsinfo.com/
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.