Job details
Job type full-time
Full job description
Wondering what’s within beckman coulter? take a closer look.
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forwardJoin a team where you can be heard, be supported, and always be yourselfWe’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associatesLook again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman coulter diagnostics is proud to work alongside a community of six fellow diagnostics companies at danaherTogether, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges!
The srClinical research associate for beckman coulter diagnostics is responsible for providing expert and overall support to clinical study teams and for all key phases of the assigned clinical studies, including planning, execution, analysis, reports & close-out.
This position is part of the beckman coulter chemistry & immunoassay business and will be in chaska, mn or be remoteAt beckman we take great research and generate the evidence to create an easy to use and highly reliable product.
This position is on the clinical affairs team and reports to the srManager of clinical operations responsible for planning and execution of a portfolio of both pre-market and post-market clinical research programs for the chemistry & immunoassay business.
In this role, you will have the opportunity to:
Participate in the key phases of the external clinical study, including planning, execution, analysis & close-outThis includes drafting the necessary documents for each phase.
Support final study site selection, contract process and site initiation visits; participates in investigators meetings and other training of site personnel on the clinical study protocol, database, and investigator responsibilities.
Execute the clinical study monitoring plan, with interim and risk-based monitoring visits to verify site compliance to the study protocol and applicable regulations.
Review data and support database development and maintenance with selected database vendor representatives.
Supports final study site selection, contract process and site initiation visits; participates in investigators meetings and other training of site personnel on the clinical study protocol, database, and investigator responsibilities.
The essential requirements of the job include:
Bachelor’s degree with 5+ years of experience related to in vitro diagnostics, or masters degree with 3 years of experience, or doctorate with 1-2 years.
Experience with clinical study management and monitoring for clinical diagnostics, medical devices or pharmaceutical products in a regulated environment.
Functional knowledge of good clinical practice, certification a plus, and familiar with us and ous requirements for design control and clinical study management.
Experience working with data management tools and understanding of databases and general statistical concepts.
Willing and able to develop appropriate internal or external technical expertise required and coordinate efforts to resolve technical issues that may arise during clinical trials.
Able to travel up to 30% of the time, depending on business needs.
It would be a plus if you also possess previous experience in:
Clinical research certification (such as ccra, ccrc)
Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heardWe believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
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 winAs 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.
