Senior Clinical Research Associate (Onsite)
Company: Beckman Coulter Diagnostics
Location: Chaska, Minnesota, United States
Job Summary:
Beckman Coulter Diagnostics is seeking a Senior Clinical Research Associate (CRA) to manage and monitor clinical trials with a focus on the in-house blood draw program. This onsite role in Chaska, MN involves cross-functional collaboration, clinical site coordination, and GCP-compliant trial execution within the Clinical Chemistry and Immunoassay (CCIA) Clinical Affairs Department.
Key Responsibilities:
Establish and manage in-house blood draw programs across US and OUS sites.
Ensure compliance with GCP, IRB regulations, and company SOPs.
Conduct onsite and remote monitoring visits (SIV, IMV, COV), ensuring documentation accuracy and protocol adherence.
Proactively identify and resolve discrepancies, deviations, and compliance issues.
Create essential study documents and maintain TMF, SSF, and ISF files for audit readiness.
Track, receive, and ship clinical study samples in coordination with the biorepository.
Assist in literature reviews, clinical documentation, data summaries, and publication planning.
Required Qualifications:
Bachelor’s degree in life sciences or related field.
Minimum 5 years of clinical trial experience in IVD, medical devices, or healthcare.
Strong problem-solving and critical thinking skills.
Effective communication with both internal and external stakeholders.
Independent IRB submissions and management experience.
Solid understanding of Good Clinical Practice (GCP).
Preferred Qualifications:
Experience in global clinical trials and monitoring.
Familiarity with electronic Trial Master Files.
Project coordination/management experience.
Compensation & Benefits:
Salary Range: $98,000 – $122,000
Bonus/Incentive Eligible
Benefits: Paid time off, medical/dental/vision insurance, 401(k)
Equal Opportunity Statement:
Danaher Corporation and its subsidiaries are equal opportunity employers. Accommodations are available upon request for candidates with disabilities.
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