Clinical Kit Coordinator

Overview

At Bio Agilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring.

Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

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.

• 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

• 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

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

• This position has no supervisory responsibilities

• Frequent supervision and instructions
• Frequently exercises discretionary authority

• Office environment
• This position requires the ability to use a computer keyboard, communicate over emails and telephone.
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

• Ability to work in an upright and /or stationary position for up to 8 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Frequent mobility needed
• Occasional crouching or stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moving) objects, and laptop computer, with a maximum lift of 30 pounds
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Requires multiple periods of intense concentration
• Performs a wide range of…