Senior Clinical Research Associate (onsite)

Beckman Coulter Dx North America; Chaska (MN); On-site; USD 98,000 - 122,000; Full time

Job summary

An established industry player in medical diagnostics is seeking a Senior Clinical Research Associate to optimize clinical trials and enhance patient outcomes. In this pivotal role, you will manage the in-house blood draw program, ensuring compliance with GCP and IRB standards. Collaborate with cross-functional teams to support the development of essential documents and maintain audit readiness. This position offers a unique opportunity to contribute to groundbreaking research in a supportive and innovative environment, where your skills will directly impact the future of healthcare. Join a team that values diversity and fosters career growth.

Benefits

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Qualifications

• 5+ years of clinical trial experience in IVD or medical device.
• Ability to independently complete IRB submissions.
• Experience with global clinical trials monitoring.

Responsibilities

• Monitor in-house blood draw program and add new study sites.
• Conduct onsite and remote monitoring visits to ensure compliance.
• Support development of study essential document templates.

Skills

Clinical Trial Management

Good Clinical Practice (GCP)

Critical Thinking

Project Coordination

Effective Communication

Education

Bachelor of Science in Life Sciences

Tools

Electronic Trial Master Files

Job description

Senior Clinical Research Associate (onsite)

Join to apply for the Senior Clinical Research Associate (onsite) role at Beckman Coulter Dx North America

Senior Clinical Research Associate (onsite)

2 weeks ago Be among the first 25 applicants

Join to apply for the Senior Clinical Research Associate (onsite) role at Beckman Coulter Dx North America

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 forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look 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 Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The Senior Clinical Research Associate for Beckman Coulter Diagnostics is responsible for monitoring the in-house 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 on-site. 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 cross-functional, detail-oriented role and want to work to build a world-class Clinical organization—read on.

In This Role, You Will Have The Opportunity To

• Set up the in-house blood draw program across US and OUS Beckman Coulter locations, ensuring the program meets the needs of cross-functional 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 in-house 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 $98,000 - $122,000. 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 Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.com.

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 [e-mail] to request accommodation.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Medical Equipment Manufacturing

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