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Clinical Kit Coordinator

BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, California, United States of America Req #135
Thursday, July 21, 2022
At BioAgilytix, 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.

In this San Diego onsite role, you will coordinate 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.

Essential Responsibilities

  • Performs and maintains documentation and compliance standards with adherence to USFDA, OECD, and MHLW Good Laboratory Practices regulations as required
  • Reviews protocols to determine type of kit needed (i.e., timepoints, anticoagulant, vacutainers)
  • Creates clinical kits including but not limited to verifying supplies needed, designing/formatting labels, labeling/handling instructions, and creating kit binders
  • Coordinates with sites to obtain contact information, receive kit requests, and follows through with site to ensure correct kit usage
  • Completes kit work orders, assembly, and shipping; coordinating with couriers to ensuring kits arrive at destination, resolving customs/invoicing issues, and ordering courier supplies as needed
  • Maintains supplies
  • Maintains a professional image particularly when dealing with sites
  • Assists in special projects as assigned by the Manager, Corporate Operations
  • Follow BioAgilytix standard operating procedures (SOPs)
  • Other duties as assigned

Minimum Acceptable Qualifications

Education/Experience:

  • High School diploma
  • Not less than one (1) year experience in a GxP-regulated laboratory or clinical environment; clinical kit experience preferred

Skills:

  • 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
  • Phlebotomy Certification is a plus

Preferred Credentials:

  • Associate degree in molecular biology, chemistry, biochemistry, immunology, biotechnology, or related field
BENEFITS AND OTHER PERKS
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), Paid Holidays (9 scheduled; 3 floating), 401k with Employer Match Employee Referral Program (up to $10k), Free Coffee, Tea, Fruit, and Snacks, Discounted Vending Machines (25 cents for everything!), Team Wellness Challenges/Events 
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

Other details

  • Pay Type Hourly
Location on Google Maps
  • BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, California, United States of America