Clinical Kit Coordinator

BioAgilytix•San Diego, CA

172d•$20 - $22•Onsite

About The Position

The Clinical Kit Coordinator is responsible for supporting the Clinical Kit Department by providing collection kits across Clinical Trials. This position coordinates the assembly and release of clinical kits to meet client expectations and maintain a high level of quality through communication, customer service, and organizational practices.

Requirements

High School diploma
Minimum of 1 year of experience in clinical kit production and/or phlebotomy
Not less than one (1) year experience in a GxP-regulated laboratory or clinical environment; clinical kit experience preferred
Working knowledge of GxP regulations
Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner
Ability to take direction well and multi-task
Acute attention to detail and excellent organizational skills
Excellent oral and written communication skills
Proficiency in MS Excel and Word

Nice To Haves

Associate degree in molecular biology, chemistry, biochemistry, immunology, biotechnology, or related field

Responsibilities

Performs and maintains documentation and compliance standards with adherence to USFDA, OECD, and MHLW Good Laboratory Practices regulations as required
Work with team members across the organization: study leads, procurement dept., and lab operations to ensure necessary information is acquired from the protocol to create the lab manuals and kit orders in a timely manner.
Track supply inventory and kits, work with Procurement Dept. to re-order supplies as required.
Maintain a working knowledge of different types of collection kits and medical devices, e.g., blood collection tubes, cryo vials, needles.
Complete kit work order process, assemble kits, and all required documentation; take part in the quality control process of the kits prior to shipping to clinical sites
Provide customs clearance support; escalate issues and advise solutions as necessary.
Centralize, streamline, and boost clinical kit processes so that lead times, redundancy, and margin for error are minimized for all clinical trials.
Other duties as assigned