Study Coordinator (6-12 Month Contract)

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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.

We are seeking a Study Coordinator for a 6-12 month contract to support our Durham, NC laboratory. This role is ideal for candidates with experience working in a GxP-regulated environment who can quickly learn systems, evaluate processes, and ensure compliance with quality standards.

This position is on-site 5 days per week.

The ideal candidate has an acute attention to detail and who brings a collaborative mindset and a commitment to scientific quality. If you thrive in a fast-paced environment, approach challenges with curiosity and ownership, and are passionate about ensuring the highest caliber of data for our clients, you’ll feel right at home at BioAgilytix.

Essential Responsibilities

• Maintain accurate study records, including sample and study documentation received.
• Track project samples received, tested, and reported.
• Track Assay QCs and testing performed during Project Sample Analysis
• Support project inventory and related activities
• Support start up and end of study activities
• May support sample management activities
• May prepare Sample Analysis worklist
• Support Sample Analysis Plan generation
• Maintain CoA’s, CoT’s, and reagent records
• Assist in Quality review data submission for Sample Analysis Projects
• May support data table assembly for Sample Analysis Projects
• Provide information for Sample Analysis Reports
• May support providing information for Client Specific Metrics and Tracking
• Adhere to safety and compliance requirements

Additional Responsibilities

• Other duties as assigned

Minimum Required Qualifications - Education and Experience

• Bachelor’s degree in biochemistry, biotechnology, immunology, molecular biology, or related field with not less than one (1) years’ experience in a laboratory environment or related field; or
• Masters’ degree in biochemistry, biotechnology, immunology, molecular biology, or related field
• Knowledge base in science with the relevant regulations for our industry

Minimum Preferred Qualifications - Skills and Experience

• Excellent oral and written communication skills
• High level of proficiency in Microsoft Office (Word, Excel, Outlook)
• Acute attention to detail
• Ability to work effectively within team to meet objectives under time constraints
• Strong organizational and project administration skills
• Experience working in a GxP environment preferred

Supervisory Responsibility

• This position has no supervisory responsibilities

Supervision Received

• Frequent supervision and instructions
• Infrequently exercises discretionary authority

Working Environment

• Primarily office, on-site at our Durham location
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
• Occasional weekend, holiday, and evening work required

Physical Demands

• Ability to work in an upright and /or stationary position for up to eight (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
• Occasional mobility needed
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including office materials and laptop computer with a maximum lift of 20 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 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 6 month, full time contract position that may extend to 12 months (possibility to convert)
• 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