Study Coordinator I

Study Coordinator I

Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, and perform the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories.

Smithers PDS is seeking a Study Coordinator I to join our team in Gaithersburg, MD. This role assists in performing study-related critical activities with supervision / oversight from the Project Manager and department management. Primary activities include : (1) performing quality review of data tables, reports, and all study supporting documentation for accuracy and adherence to SOPs, GLP guidelines, and established laboratory policies and (2) identifying issues and deviations that affect the quality of study-related data and communicating these to the Project Manager or appropriate department manager.

This position is an entry-level professional role. It is paid on a salary basis and is classified as an exempt position. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments. Position is generally eligible for a hybrid work schedule with at least three days on-site once all training requirements have been adequately met and proficient performance is consistently demonstrated.

Salary for range for this position is $50,000 - $65,000 per year. Salary and job title will be commensurate with experience and qualifications. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan, and PTO.

Primary Responsibilities :

• Review run folders, notebooks and other study-related materials and document deviations from SOPs, regulations, and / or client specifications.
• Assure that all QC and QA findings are responded to in a timely fashion and are complete and accurate.
• Assure that all run folders and data tables move through the internal process, including the Quality Assurance department, in sufficient time to meet client timelines.
• QC review data summary tables from Watson LIMS and various Excel spreadsheet formats.
• Organize and maintain project data so it can be submitted for audit or archive in a timely manner.
• Attend client conference calls and prepare / provide agenda and meeting minutes when required.
• Other duties as assigned.

Additional Requirements :

Corporate Responsibilities :

Qualifications :

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws.