Danaher Corporation Senior Clinical Research Associate in Vista, California
At Leica Biosystems our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our culture, and we know that “Every Moment Matters” when it comes to cancer diagnostics. A global leader in workflow solutions and automation, Leica Biosystems is the only company to own the workflow from biopsy to diagnosis, so we are uniquely positioned to break down the barriers between each of these steps. If you're a Clinical Research Associate with IVD or Medical Device experience and are passionate about developing innovative solutions that enable accurate diagnoses, we want to hear from you!
The Senior Clinical Research Associate (Sr CRA) understands business needs and ensures adherence to Good Clinical Practice (GCP) and standard operating procedures (SOP) for conducting device clinical studies. You will be responsible to prepare and carry out clinical operations study tasks, including writing documents (may include plan, protocol, report); as well as the initiation, monitoring, and completion of clinical studies for verification and/or validation. As an active member of Clinical Operations within the Global Clinical & Medical Affairs organization, this role represents the clinical group on multi-functional teams to ensure project requirements are met and clinical trials are conducted compliantly and successfully.
Responsibilities we will trust you with:
Uses the Danaher Business System and tools in the timely and high-quality execution of studies for pre-market and post-market programs.
Uses documented process 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, interim monitoring/query resolution, timely review and analysis of data generated, and closure activities.
Develops ongoing relationships and leads communications with clinical investigators and their staff regarding activities in all phases of the trials to ensure study quality and timely results.
Provides technical support and training to investigators and their team regarding device trial information, the protocol, subject enrollment, clinical and regulatory requirements.
Solves tough problems related to clinical strategy and operations and exercises judgment based on the analysis of multiple sources of information
Has knowledge of clinical research standard methodologies and how the department integrates with others; is aware of the competition and the clinical evidence factors that provide differentiation in the market
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 IVD and medical device products, including TMF and ISF management, etc.
Provides up-to-date clinical study progress to Clinical Program Lead and/or teams as requested.
Acts as resource and mentor for other teammates, and may lead projects with manageable risks and resource demands
Your skills and experience that matter most for this role:
Minimally, Bachelor’s degree and at least five years in-depth clinical operations experience and knowledge of standard methodology, preferably in vitro diagnostic and/or medical device studies, or equivalent combination of education and experience
Demonstrated ability to explain difficult or critical information to diverse audiences, including senior leaders
Proven ability to solve problems in a regulated environment; Demonstrated experience in critical thinking and evidence analyzation skills
Excellent organizational skills and ambition to continuously improve together with the business
Able to be an independent contributor as well as a great teammate to impact a full range of customer, operational, project or service activities within own team and cross-function teams
Strong technical background to understand and communicate current and new technologies in oncology
Location: HYBRID Preferably near a Leica Biosystems Site in Danvers, MA or Vista, CA
Travel: 25% -30% travel required
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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
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