Study Coordinator

Smithers - Medical Device Testing; Gaithersburg (MD); Hybrid; USD 50,000 - 75,000; Full time

Job summary

Smithers PDS LLC (Pharmaceutical Development Services) seeks a Study Coordinator I or II to join our Gaithersburg, MD team. The role supports the Project Manager with study data review, plan drafting, and timely archival of study materials.

The position offers a hybrid work schedule with on-site presence three days after training and proven performance. Ideal candidates bring GLP familiarity, strong organizational skills, and experience in analytical labs.

Qualifications

• 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.
• Bachelor’s Degree in Biological Sciences or equivalent experience preferred for Study Coordinator II.
• Minimum of 2 years in a direct laboratory bench role or study support role such as QC/QA at a GLP, GMP facility, with at least 1 year in an analytical laboratory under GLP regulation.

Responsibilities

• QC review data summary tables from Watson LIMS and various Excel formats.
• QC review report drafts and finalization.
• Organize and maintain project data for audit submission or archiving.
• QC run folders and notebooks; conduct back archivist related activities.
• Assist Project Manager with meeting client deadlines; know status of active projects and timelines.
• Create data summary tables from Watson LIMS and Excel formats.
• Ensure study-related information is archived when reports are finalized.
• Assist in delivering plans and reports to clients.
• Draft Analytical Plans for Transfer, Validation, and Sample Analysis.
• Review run folders, notebooks, and records to document deviations from SOPs.

Skills

Attention to detail

Organized

Team oriented

Critical thinker

Pro-active communicator

GLP knowledge

Education

Associate degree in Biological Sciences

Bachelor’s Degree in Biological Sciences

Tools

Watson LIMS

Excel

Word

Job description

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.

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.

Ideal attributes include excellent attention to detail, highly organized and efficient, team oriented, self‑motivated, critical thinker, great pro‑active communicator, measures success through his/her contributions to support overall team and business success, adaptable viewing change as an opportunity, is not deterred by challenges, and is willing and able to put in the extra time and effort to get the job done.

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 Responsibilities

• 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 Responsibilities

• 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 Qualifications

• 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 Qualifications

• 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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