Leica Biosystems associates know that every moment matters when it comes to cancer diagnostics. When you join our team as a Clinical Research Associate, you're helping develop solutions that enable accurate diagnoses to turn anxiety into answers. If you are interested in supporting products you can feel passionate about, we want to hear from you!
The CRA prepares and executes clinical operations study tasks, including: documents (may include plan, protocol, report), initiation, monitoring, and completion of clinical studies for verification and/or validation. You will represent the Global Clinical Affairs group on multi-functional core teams to ensure project requirements are met and clinical trials are conducted successfully. Additionally, this role ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting device clinical studies.
Responsibilities we will trust you with:
Under supervision of the Clinical Program Lead, works with relevant departments (R&D, Regulatory Affairs, Product Support, Program Management, Marketing) to aid in design and preparation of clinical and analytical performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms.
With minimum supervision, completes all activities related to the set-up, initiation, execution and close-out of device clinical trials including, site selection, collection and timely review and analysis of data generated.
Schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of data.
Communicates with study investigators via phone, fax, email, onsite and/or letters regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
Leads the development, organization, implementation and completion of clinical studies according to FDA standards and GCP. Provides technical training and monitoring.
Coordinates daily activities of trial sites; assists sites on planning and implementing subject recruitment activities. Educates and assists sites to ensure timely subject screening and enrollment. Provides technical support and training to clinical investigators and their staff in regard to device trial information, the protocol, clinical and regulatory requirements and device implant support.
Conducts assessments of complications and serious adverse events, including reviewing and reconciling data and documentation about event.
Conducts quality control to ensure compliance to the study protocol, trial material storage and accountability. Supports IRB submissions, addendums and renewals.
Participate in the submission of clinical data and study reports to support regulatory submissions. Assists in evaluation and analysis of clinical data.
Remains current with regulatory requirements for IVD and medical device products and represents Global Clinical Affairs on multifunctional teams tasked with preparing responses to regulatory agencies.
Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database.
Builds site specific study budgets, initiates and supervises contract origination, compliance approval, and execution. Completes the tracking of budgets for studies.
Your areas of knowledge and expertise that matter most for this role:
The qualified candidate must have a BA/B.S or equivalent and over two years related experience and/or training; or equivalent combination of education and experience.
Good knowledge of the in-vitro diagnostics and medical device industry preferred including knowledge of regulatory requirements
Solid understanding of databases (e.g., Excel, Access), database management, and statistical applications
Good technical background to understand and communicate current and new technologies
Laboratory experience is desirable
Ability to work on multiple projects simultaneously
Able to work within constraints of time and budget
30% -40% travel required
Location: This role works remotely within a commutable distance to Vista, CA.
What we have to offer: Check out our benefits here: https://danaherbenefitsinfo.com/
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.
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.
When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
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.
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