Clinical Research Monitoring (CRA)

As the Clinical Research Associate II, you will be responsible 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. 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.

Manage Clinical Studies required for the establishment of the performance of an IVD product.

Authors clinical performance study monitoring plan, protocol, ICF, etc. 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 ensure compliance with GCP and regulatory requirements.

Bachelor's degree in Life Sciences, Biomedical Sciences, or related field (advanced degree preferred).

Work Experience: 2 years' experience in clinical research (clinical trials execution role, preferably in an IVD, device or pharma 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.

Location: This position must be based in Seattle, Washington and requires the employee to be located within commuting distance of the office.

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!

This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Fraud Alert : Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.

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