Senior Study Coordinator (Medtech)

TL;DR

Senior Study Coordinator (Medtech): Coordinating bioanalytical laboratory studies for sample testing under GLP and GCLP standards with an accent on study documentation, project tracking, and data quality control. Focus on drafting protocols, managing study schedules, and ensuring compliance with regulatory requirements for complex biological projects.

Location: Gaithersburg, Maryland, USA (Onsite)

Salary: $67,900 – $101,000 per year

Company

hirify.global provides advanced bioanalytical platforms and services for biological sample testing and assay development.

What you will do

• Draft protocols, sample analysis plans (SAPs), amendments, and bioanalytical reports.
• Perform Quality Control (QC) review of study data to ensure compliance with GLP/GCLP requirements.
• Coordinate project timelines and deliverables between Bioanalytical Principal Investigators, other departments, and clients.
• Manage study documentation for multiple concurrent projects of moderate to high complexity.
• Maintain organized study files and prepare them for archiving upon study conclusion.
• Collaborate with data management teams to create mock reports and test data transfers.

Requirements

• Bachelor’s degree in biology, chemistry, or a related scientific discipline (Master’s preferred).
• Minimum of 2 years of experience in biological sample testing or reagent/assay development.
• Experience in a clinical testing laboratory or contract research organization (CRO) is highly preferred.
• Training and experience with GLP and/or GCLP standards.
• Strong understanding of ligand-binding assays and scientific fundamentals.
• Proficiency in MS Office suite and SharePoint.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage including prescription benefits.
• 401(k) plan with company matching.
• Paid vacation, sick leave, holidays, and parental leave.
• Flexible spending accounts and company-paid disability insurance.
• Voluntary perks such as fitness club membership contributions and pet insurance.