Bioagilytix28d ago

Study Coordinator (6-12 Month Contract)

DurhamCONmid

OtherCoordinator

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At BioAgilytix, we are passionate about premier science and the impact it has on our world.

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OtherCoordinator

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.

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

Other duties as assigned

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

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

This position has no supervisory responsibilities

Frequent supervision and instructions

Infrequently exercises discretionary authority

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

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

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