The Research Associate is responsible for executing formulations study activities to ensure quality and timely completion of studies. These include:
• Write procedures, i.e., Formulation Batch Records and Dispense definitions, for the preparation, aliquoting, and weigh outs of dosing formulations.
• Review protocols and make sure protocol requirements are met. Calculate Test Article requirements based on protocols and study designs.
• Coordinate study activities with the Study Director, Data Management, Formulations Supervisor, other technical personnel, and Sponsor in the planning, conducting, and reporting of studies. Schedule preparation activities to match InLife and Formulations schedules.
• Ensure raw data records are accurate, complete, and in appropriate order. Work with Study Directors and Study Coordinators in preparing responses to internal and external Quality Assurance audits.
• Meet protocol, SOP and GLP requirements.
• Write SOP, protocol, and GLP deviations and review deviations written by others.
• Assist in training of formulations technicians in dose formulation preparations and use of Dispense.
• Perform special laboratory and study related assignments as assigned by Laboratory management, e.g., order materials,
• Perform laboratory preparations of dose formulation procedures
• Evaluate new technologies and procedures for use in the department, under supervision
• Education: Bachelor’s degree (B.S./B.A.) preferably in chemistry
• Experience: Two to four years experience in formulations preparation.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Preferred expereince with Dispense.
• Certification/Licensure: LAT, ALAT, or LATG preferred.