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.

The Clinical Kit Coordinator 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.
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 Senior Manager of Project Operations
• Follow BioAgilytix standard operating procedures (SOPs)

Additional Responsibilities

• Other duties as assigned

Minimum Preferred Qualifications
Education/Experience

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
• Proficiency in LIMS and Quality Management software packages

Preferred Credentials

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

Supervisory Responsibility

• This position has no supervisory responsibilities

Supervision Received

• Frequent supervision and instructions
• Frequently exercises discretionary authority

Working Environment

• Primarily laboratory environment, including use of personal protective equipment such as safety glasses, lab coats and gloves
• Occasional office environment
• Exposure to biological fluids with potential exposure to infectious organisms
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
• Potential exposure to skin and lung irritants, toxic materials, and hazardous waste
• Exposure to fluctuating temperatures on rare occasions

Physical Demands

• 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 to operate lab equipment
• 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, including laboratory samples, laboratory equipment, and laptop computer, with a maximum lift of 30 pounds
• Ability to use personal protective equipment and work effectively in freezers as cold as -80°C
• 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 variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Ability to perform under stress and multi-task
• Regular and consistent attendance

Position Type and Expected Hours of Work

• This is a full-time position
• Some flexibility in hours is allowed, but the employee must be available during the "core" work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required

Pay Range: The pay range for this position is $20.00 - $22.00 per hour

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.


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