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SoBran is seeking an Associate Study Director for our BioScience Division. This position will be located in Burtonsville, Maryland.
Author, review and maintain study protocols and amendments as per 21 CFR, part 58
Interpret and analyze data for final reports
Monitor GLP studies in conjunction with QA and the study director
Communicate study events and updates to clients and study directors
Ensure all deviations from protocols and SOP's are properly documented, addressed, and reported to the study director and client
Review and approve study plans, animal orders, formulation procedures, randomizations and study timelines
Serve as liaison between the company and study subcontractors
Coordinate the receiving and shipping of test articles and study samples to and from clients and subcontractors
Work with facility management to develop study schedules
Conduct meetings with the technical staff to review study protocols prior to commencement of studies
Interact with the technical teams on a regular basis to ensure studies are being conducted to meet the requirements of protocols
Host clients during site visits
Assist with regulatory inspections
Perform all other duties as assigned
Bachelor's degree, preferably in animal or biological sciences; may be substituted for equivalent experience
Have 6 years' experience in a GLP laboratory animal facility, 3 years of which are in a technical writing position
Must have excellent customer service, written communication, and organizational skills
Experience preparing study protocols, amendments, and reports for GLP compliant studies
Proficient in Microsoft Office Suite
Experience working with a data capturing system
SoBran, is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability, protected veteran or other status protected by federal, state, and local laws.