Description
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.
Roles and Responsibilities
- 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.
Qualifications and Experience
- 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.
Preferred Experience
- Electronic data capture (EDC) system and eTMF system (Florence).
- CLSI guidelines and Good Laboratory Practice (GLP).
- Clinical research certification (i.e., SOCRA, CCRA, CCRC).
