Our team helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA. 
 
Our experienced medical device and extractables and leachables (E&L) testing teams will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO.

Smithers also supports the pharmaceutical industry and the development of biologics and vaccines from discovery through phase IV, with expertise that includes bioassays and high sensitivity assays. Our scientists have expertise in large molecule bioanalysis assay development, validation, and sample analysis.

Industry: Medical Equipment Manufacturing
Company Size: 501-1,000 employees

Smithers - Medical Device Testing

Savvy Admin PROD

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 and validate new 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.

**Role**

Smithers PDS is seeking a Study Coordinator I or II to join our team in Gaithersburg, MD. The job level will be commensurate with previously related experience. This role assists in performing study-related critical activities with supervision/oversight from the Project Manager and department management. Primary activities include:

- Study Coordinator I: (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.

- Study Coordinator II: (1) Watson and Excel data retrieval, (2) QC of data tables and reports and all study supporting documentation, (3) identifying issues and deviations that affect the quality of study-related data and communicating these to the Project Manager or appropriate department manager, and (4) drafting study plans and reports as needed.

This position is classified as exempt and paid on a salary basis. 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.

The annualized salary range for a Study Coordinator I or II position is $50,000 - $65,000 or $60,000 - $75,000, respectively. Experience and qualifications will determine salary and job level. 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**

- Study Coordinator I

-

- QC review data summary tables from Watson LIMS and various Excel spreadsheet formats.

- QC review report drafts and finalization.

- Organize and maintain project data so it can be submitted for audit or archive in a timely manner

- QC run folders and notebooks

- Conduct back archivist related activities

- Study Coordinator II

- Assist the Project Manager with meeting client deadlines. This requires a complete understanding of the status of each active project and the agreed upon project timelines and deliverables.

- Create data summary tables from Watson LIMS and various Excel spreadsheet formats.

- Assure that all study-related information is archived on date that the report is finalized.

- Assist the Project Manager in delivering , plans, and reports to clients.

- With input and supervision from the Project Manager, assist in drafting Analytical Plans and to support all phases of the business (Transfer, Validation and Sample Analysis) using Smithers or client specific templates.

- Conduct back archivist related activities

- Review run folders, notebooks and other study-related materials and document deviations from SOPs, regulations and/or client specifications.

- QC run folders and notebooks

- Assure that all run folders, data tables and reports move through the internal process including QAU in sufficient time to meet client timelines.

- Assure that all QC and QA findings are responded to in a timely fashion and are complete and accurate.

- Attend Client Conference calls and provide meeting minutes for client conference calls 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).

**Qualifications**

- Study Coordinator I

- 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.

- Study Coordinator II

- Minimum of a Bachelor’s Degree in Biological Sciences or equivalent experience preferred.

- Minimum of 2 years in a direct laboratory bench role or study support role such as QC/QA at a GLP, GMP facility, at least 1 of which occurred in an analytical laboratory environment under GLP regulation.

- Immunochemistry experience is preferred.

- Functional knowledge of Watson LIMS is a plus.

- 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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Study Coordinator

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