What are the responsibilities and job description for the Study Coordinator I position at Smithers?
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 - $65,0000 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 :
PharmaJobs
LI-MV1
Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Salary : $50,000 - $650,000
