- Responsible for consistently engaging with your assigned clinical sites to influence in meeting speedy contract execution, overall site initiation and enrollment targets, produce high quality data in accordance with GCP, IRB policies and procedures, PHI protection and applicable regulations. 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.
- Contribute to case report form design and EDC user acceptance testing and other data management related activities, run study data reports to track and stay compliance with the study Monitoring Plan and Data Management Plan.
- Conduct onsite and/or remote site meetings, perform proactive data review to identify discrepancies and protocol deviations, overseeing corrective actions to drive compliance with study protocol(s) and applicable Standard Operating Procedures (SOP).
- Meet expected timelines for completion of clinical activities and entry of inputs and metrics into study management trackers.
- Bachelor's degree or equivalent in the life sciences or related field required with 5+ years' experience in vitro diagnostics (IVD), Medical Device, or Healthcare clinical field, Master's degree in field with 3+ years, or Doctoral degree with 0-2+ years.
- Demonstrated agility with processes and details, ability to apply critically-thinking, analyze data (using analytical tools), and solve complex problems.
- Strong work ethic and demonstrated ability to deliver assignments on time, and effectively communicate and escalate.
- High proficiency in Microsoft Office tools (i.e., Excel and Outlook)
- Able to travel up to 50% regionally.
- Electronic data capture (EDC) system and eTMF system (Florence)
- CLSI guidelines and Good Laboratory Practice (GLP)
- Clinical research certification (i.e., SOCRA, CCRA, CCRC)
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Senior Clinical Research Associate - Chaska, United States - Beckman Coulter, Inc.
2 days ago
Description
At first glance, you will see that for more than 80 years we have 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 are building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you will 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 are working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
The Sr. Clinical Research Associate (CRA) for Beckman Coulter Diagnostics is responsible for engaging clinical sites and supporting activation, optimal enrollment, data quality, and other clinical activities to generate clinical evidence that will support product registration and/or product market clearance/approval.
This position is part of the Clinical Chemistry and Immunoassay (CCIA) Clinical Affairs department. 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, who is responsible for managing the clinical operations for a cardiac study. If you thrive in a an amazing, multifunctional, fast paced role and want to work to build a world-class clinical affairs organization-read on.
In this role, you will have the opportunity to:
The salary range for this role is $85,000 to $115,000. 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. We may ultimately pay more or less than the posted range. 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.
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
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.
