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.
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 requirementsAdditional Responsibilities
Other duties as assignedMinimum 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 preferredSupervisory Responsibility
This position has no supervisory responsibilitiesSupervision Received
Frequent supervision and instructions
Infrequently exercises discretionary authorityWorking 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 requiredPhysical 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 attendancePosition 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
