Clinical Study Coordinator (Hybrid) — GLP Data QC & Planning

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) 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.