The
Clinical Research Associate III is rsponsible for planning, execution and oversight of clinical studies in compliance with ICH-GCP and IVD clinical guidelines, applicable regulatory requirements, and company SOPs. This role participates in the management of clinical study budgets and timelines, as well as all the improvement of the clinical quality system. This role represents Clinical Affairs collaborates cross-functionally with Regulatory Affairs, R&D, Quality, Marketing, and external partners to deliver high-quality clinical data and evidence supporting product registration and commercialization of Bio-Rad diagnostic products.
How You'll Make An Impact:- Manage Clinical Studies required for the establishment of the performance of an IVD product.
- Authors clinical performance study strategy, plan, protocol, ICF, study reports, etc. in compliance with applicable regulations and standards.
- Selects, qualifies and onboards clinical study sites with the execution of study agreements and IRB approvals.
- Fosters effective communication and collaboration with study sites and/or CROs, and oversights the study execution from study site initiation, to site closeout.
- Monitors study progress, enrollment, data integrity, risk management, and ensures compliance with GCP and regulatory requirements. Mentors junior CRAs on project clinical operations.
What You Bring: - Education: Bachelor's degree in Life Sciences, Biomedical Sciences, or related field (advanced degree preferred).
- Work Experience: 5 years' (3 years' with advanced degree) experience in clinical research with at least 3 years of clinical trials execution role, preferably in an IVD company.
- Experiences of using eTMF and EDC platforms during clinical research.
- Deep knowledge of FDA clinical research regulations, and ICH-GCP, ISO 13485, ISO 20916.
- Excellent written and effective verbal communication skills, and people management experience.
Location: This position must be based in
Seattle, Washington and requires the employee to be located within commuting distance of the office.
Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.
Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more!
Compensation: The estimated base salary range for this position is $103,600 to $142,500 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.
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