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, as well as performing 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.

• 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.

• Knowledge of GLP.
• Ability to multi-task and participate in multiple studies concurrently.
• Ability to ensure high quality data while working under the pressure of strict deadlines.
• Overtime and weekend work as required.
• Work may require the use of PPE (personal protective equipment).

• Adherence to laboratory health and safety procedures.
• Adherence to Standard Operating Procedures (SOPs) & applicable company policies/ guidelines.
• Adherence to federal and/or local regulations, as applicable.

• Minimum of an associate degree in Biological Sciences or equivalent experience preferred.
• Prior experience reviewing data in detail and identifying errors.
• Experience in an analytical laboratory. GLP/GCP Immunochemistry environment is preferred, but not required.
• Extremely strong competence using Microsoft Word and Excel especially with various formatting features.
• Must be detail-oriented, and well organized with exceptional written and oral communication skills.
• Must have sufficient scientific background to understand scientific concepts of ligand binding assays (biomarkers, PK, immunogenicity, and cell-based assays).

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