Clinical Research Associate II

Bio-Rad Laboratories; Seattle (WA); On-site; USD 83,000 - 114,200; Full time

Benefits offered by this job

Competitive compensation package

Medical plans for you and family

Employee stock purchase plan

Life and disability insurance

401k plus profit sharing

Job summary

Bio-Rad Laboratories seeks a Clinical Research Associate II to plan, execute, and oversee clinical studies in accordance with ICH-GCP and IVD guidelines. Based in Seattle, you will collaborate across Regulatory Affairs, R&D, Quality, Marketing, and external partners to deliver robust clinical data for product registration and commercialization of Bio-Rad diagnostic products.

You will manage study budgets and timelines, monitor enrollment and data integrity, and ensure compliance while supporting

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Sciences, or related field (advanced degree preferred).
• 2 years' experience in clinical research (clinical trials execution role, preferably in an IVD, device or pharma company).
• Experience 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 verbal communication skills, and people management experience.

Responsibilities

• Manage clinical studies required for establishing IVD product performance.
• Author clinical performance monitoring plan, protocol, ICF, etc. in compliance with applicable regulations.
• Select, qualify and onboard clinical study sites with study agreements and IRB approvals.
• Foster effective communication and collaboration with study sites and CROs, and oversee study execution from initiation to closeout.
• Monitor study progress, enrollment, data integrity, risk management, and ensure compliance with GCP and regulatory requirements.

Skills

2 years clinical research experience

eTMF and EDC platforms

FDA regulations & ICH-GCP

ISO 13485 & ISO 20916 knowledge

Excellent communication skills

People management experience

Education

Bachelor's degree in Life Sciences or related field

Job description

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.

How You'll Make An Impact

• Manage Clinical Studies required for the establishment of the performance of an IVD product.
• Authors clinical performance study monitoring plan, protocol, ICF, 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 ensure compliance with GCP and regulatory requirements.

What You Bring

• Education: 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.
• 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 $83,000 to $114,200 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.

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. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement

Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. 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.

Agency Non-Solicitation

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.