What are the responsibilities and job description for the Study Coordinator position at Default Brand?
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.
The Study Coordinator assists in performing project 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.
Qualifications:
Minimum of a Bachelor’s Degree in the Biological Sciences or equivalent experience preferred. Minimum of 1 year in a QC/QA role at another GLP, GMP facility. Minimum 1 year in an analytical laboratory environment which is under GLP regulation. Immunochemistry experience is required. Extremely strong competence using Microsoft Word and Excel especially with various formatting features. Functional knowledge of Watson LIMS a plus. Must be detail oriented, well organized with exceptional communication skills. Must have sufficient scientific background to understand scientific concepts of ligand binding assays (biomarkers, PK, immunogenicity and cell-based assays). Must be familiar with all with GLP requirements.
Corporate Responsibilities:
• Adherence to laboratory health and safety
• Adherence to Standard Operating Procedures (SOPs)
• Adherence to applicable company policies and guidelines
• Adherence to federal and/or local regulations as applicable
• 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.
• Attend client conference calls and prepare/provide agenda and meeting minutes when required.
• Other duties as assigned.
Additional Requirements:
• 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).
Professional Responsibilities: (if applicable)
• Attend continuing education courses, as appropriate.
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