BioAgilytix
Location
Durham, North Carolina
The Study Coordinator will be responsible for maintaining accurate study records, tracking project samples, and supporting assay quality control testing performed during sample analysis. This role also involves supporting study start-up, end-of-study activities, and maintaining essential documentation like CoAs and reagent records.
Candidates must have a Bachelor's degree in a relevant scientific field with at least one year of laboratory experience, or a Master's degree, along with knowledge of relevant industry regulations. Preferred qualifications include experience in a GxP environment, excellent communication skills, acute attention to detail, and strong organizational abilities.
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
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
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