Clinical Trials Sr. Rep - Advanced in Carpinteria, CA at Volt

Date Posted: 10/30/2018

Job Snapshot

Job Description

Clinical Research Associate- Carpinteria, CA.

Trials Primary 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 assist in the development and design of databases and Data Report Forms in collaboration with Clinical Trial Managers and Clinical Affairs Specialists, and prepare and 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:
1 - Your professional interactions and communication skills with study sites and pharmaceutical partners.
2 - Your ability to work in a fast moving self-driven team.
3 - Your ability to organize and coordinate documentation related to clinical trials running globally. 

Bachelor´s degree in biological sciences. 
* A minimum of 5 years of Clinical Trial support experience for diagnostic, medical device or pharmaceutical products.
* A solid understanding of project management and familiarity with project management tools.
* Experience in CRO/vendor management and contracting.
* Understand requirements of various controlling bodies and framework.
* Knowledge of oncology clinical trials is preferred.
* Experience working in parallel projects teams. 
* High work capacity may be required at certain times in high priority projects.
* The ability to organize and motivate others.
* Flair, enthusiasm and leadership when faced with challenges.

Volt is an Equal Opportunity Employer