Senior Clinical Research Associate onsite

At first glance youll see that for more than 80 years weve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard be supported and always be yourself. Were building a culture that celebrates backgrounds experiences and perspectives of all our associates. Look again and youll 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 Danaher. Together were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges.

The Senior Clinical Research Associate for Beckman Coulter Diagnostics is responsible for monitoring the inhouse blood draw program and coordinating the efforts to add new study sites to the program.

This position is part of the Clinical Chemistry and Immunoassay (CCIA) Clinical Affairs Department located in Chaska MN and will be onsite. At Beckman Coulter our vision is to relentlessly reimagine healthcare one diagnosis at a time.

You will be a part of the CCIA Clinical Affairs Team and report to the Clinical Affairs Manager responsible for planning and executing IVD clinical trials. If you thrive in a crossfunctional detailoriented role and want to work to build a worldclass Clinical organizationread on.

In this role you will have the opportunity to:

• Set up the inhouse blood draw program across US and OUS Beckman Coulter locations ensuring the program meets the needs of crossfunctional teams and complies with GCP IRB policies and procedures and applicable Standard Operating Procedures (SOP).
• Conduct onsite and remote monitoring visits (SIV IMV COV) to perform proactive document/data review to identify discrepancies and protocol deviations overseeing corrective actions to drive compliance with study protocol(s). Effectively escalate and collaborate with site personnel and internal team members to propose solutions to sustain good compliance.
• Support development of study essential document templates (e.g. study guides study
  tools/worksheets) and ensure Trial Master File (TMF) Sponsor Site Files (SSF) and Investigator Site Files (ISF) are maintained and kept current; assist in audit readiness and preparation.
• Support the inhouse biorepository by receiving shipping and tracking clinical study samples.
• May perform other clinical project activities such as drafting documents reports data summaries presentations conducting literature searches publication and/or podium planning.

The essential requirements of the job include:

• Bachelor of Science degree in the life sciences or related field required with 5 years of clinical trial experience in vitro diagnostics (IVD) medical device or healthcare clinical field.
• Demonstrated agility with processes and details ability to apply critical thinking and solve complex problems.
• Effectively communicate with internal and external stakeholders who possess various levels of clinical research experience.
• Ability to independently complete IRB submissions (initial review change in research continuing review closeout report).
• Thorough understanding of Good Clinical Practice (GCP).

It would be a plus if you also possess previous experience in:

• Global Clinical Trials Monitoring/Management
• Experience with electronic Trial Master Files
• Project Coordination/Management

The salary range OR the hourly range for this role is $98000 $122000. 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. 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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

#LILM3

Join our winning team today. Together well accelerate the reallife impact of tomorrows 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.

For more information visit www.danaher.

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.

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 to request accommodation.