Clinical Research Associate II

Bio-Rad Laboratories•Seattle, WA

6d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Life Sciences, Biomedical Sciences, or related field
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
People management experience.

Nice To Haves

Advanced degree preferred

Responsibilities

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.