Study Coordinator I/II

Smithers PDS LLC brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop and validate new methods and performs assays for samples from over 100 clinical trials in FDA-regulated processes. Expert scientists handle large molecule bioanalysis, assay development, validation, and sample analysis in GLP, GCP, and CLIA compliant labs.

Smithers PDS seeks a Study Coordinator I or II in Gaithersburg, MD, with job level based on related experience. This role assists in study-related critical activities under supervision from the Project Manager and department management. Primary activities focus on quality review and data handling for both levels.

Study Coordinators perform QC reviews of data tables from Watson LIMS and Excel, reports, run folders, and notebooks. They identify deviations from SOPs, GLP guidelines, and policies, communicating issues to management. Responsibilities include organizing project data for audits and archives.

Level II roles add data retrieval, drafting study plans and reports, and assisting Project Managers with client deadlines and deliverables. The position supports hybrid schedules after training, with extended hours possible for client commitments. Growth aligns with experience in pharmaceutical development services.