BioAgilytix · 7 hours ago
Clinical Kit Coordinator
San Diego, CA
Full-time
Onsite
Entry Level
$20/hr - $22/hr
1+ years expBioAgilytix is a company dedicated to premier science and impacting the world through innovative bioanalytical services. The Clinical Kit Coordinator is responsible for supporting the Clinical Kit Department by coordinating the assembly and release of clinical kits for clinical trials, ensuring quality and compliance with regulations.
BiotechnologyLifestyle
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
Qualification
Required
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
Preferred
Associate degree in molecular biology, chemistry, biochemistry, immunology, biotechnology, or related field
Benefits
Medical Insurance (HDHP with HSA; PPO)
Dental Insurance
Vision Insurance
Flexible Spending Account (medical; dependent care)
Short Term Disability | Long Term Disability Life Insurance
Paid Time Off (4 weeks per year)
Parental Leave
Paid Holidays (9 scheduled; 5 floating)
401k with Employer Match
Employee Referral Program
Company
BioAgilytix
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development.
1001-5000 employees
H1B Sponsorship
BioAgilytix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (8)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2016-02-22Acquired
Leadership Team
Davide Molho DVM
Chief Executive Officer
Maureen Marchek
Chief Financial Officer
Company data provided by crunchbase