Dako North America, an Agilent Technologies Company
Location: California (Carpinteria)
We are searching for an experienced Clinical Trials Research Associate (CRA) to join Medical & Clinical Affairs at Dako. As a CRA, your main responsibilities will be to plan, coordinate and support the day-to-day running of clinical studies for cancer in vitro diagnostics (IVDs), with a focus on Companion Diagnostics (CDx), to support regulatory applications and scientific studies. You will develop and design database and Data Report Forms in collaboration with Clinical Trial Managers, Clinical Affairs Specialists, and prepare an follow-up on queries.
Your work includes identifying, evaluating and qualifying clinical study sites, assist with site contracting, vendor/CRO management, ensure monitoring, responsibility for study files, guiding projects in conforming to requirements, and acting as point of contact (internal and external) for study related issues.
The CRA will assist in distribution of trial related information to relevant persons/bodies, coordinate EC/IRB approvals, and identify and resolve problems at study sites.
You will be measured on:
Your professional interactions and communication skills with study sites and pharmaceutical partners.
Your ability to work in a fast moving self-driven team.
Your ability to organize and coordinate documentation related to clinical trials running globally.