Study Coordinator I/II — Hybrid GLP Data QC & Study Support

Smithers Group; Gaithersburg, Northern (MD, KY); Hybrid; USD 50,000 - 75,000; Full time

Benefits offered by this job

Health insurance options

Dental insurance

Vision insurance

401K retirement plan

PTO

Job summary

Smithers PDS LLC (Pharmaceutical Development Services) seeks a Study Coordinator I or II in Gaithersburg, MD. Role supports study activities with supervision from the Project Manager, requiring strong attention to detail and organizational skills.

Primary tasks include data QC, report drafting, and maintaining study documents for audit. Hybrid work with on-site and remote elements, salary range $50,000–$75,000 based on level and experience, plus comprehensive benefits.

Qualifications

• Minimum of an associate degree in Biological Sciences or equivalent experience preferred.
• Minimum of a Bachelor’s Degree in Biological Sciences or equivalent experience preferred.
• Experience in an analytical laboratory, GLP/GCP environment preferred.

Responsibilities

• QC review data summary tables from Watson LIMS and Excel formats.
• QC review report drafts and finalization.
• Organize and maintain project data for audit or archive.
• QC run folders and notebooks.
• Assist the Project Manager with meeting client deadlines and timelines.
• Draft Analytical Plans and support Transfer, Validation and Sample Analysis.

Skills

Attention to detail

MS Word & Excel

Immunochemistry experience

Data review experience

Education

Bachelor’s Degree in Biological Sciences

Associate Degree in Biological Sciences

Tools

Watson LIMS

Job description

Smithers PDS LLC (Pharmaceutical Development Services) seeks a Study Coordinator I or II in Gaithersburg, MD. Role supports study activities with supervision from the Project Manager, requiring strong attention to detail and organizational skills.

Primary tasks include data QC, report drafting, and maintaining study documents for audit. Hybrid work with on-site and remote elements, salary range $50,000–$75,000 based on level and experience, plus comprehensive benefits.