Senior Study Coordinator

Responsibilities

• Draft protocols, sample analysis plans (SAPs), amendments, bioanalytical reports, and study schedules.
• Review study records and reports for compliance against protocols, SOPs, and GLP/GCLP requirements.
• Perform Quality Control review of study data and collaborate with Bioanalytical Principal Investigators (BPIs) to resolve issues.
• Manage study documentation for multiple concurrent, high-complexity projects.
• Assist BPIs in analyzing and evaluating data for reports and managing data transfers to clients.
• Maintain organized and up-to-date study files, including schedules, protocols, and correspondence.
• Monitor study phases and update project tracking systems.
• Prepare study files for archiving at the conclusion of studies.

Requirements

• Bachelor's degree in biology, chemistry, or a related scientific discipline.
• Minimum of 2 years of experience in biological sample testing or reagent/assay development.
• Strong understanding of ligand-binding assays.
• Proficiency in MS Office suite.
• Familiarity with electronic file management using SharePoint.
• Excellent organizational and communication skills with the ability to meet deadlines in a demanding environment.

Preferred Qualifications

• Master's degree in a scientific discipline.
• Experience in a clinical testing laboratory or Contract Research Organization (CRO).
• Training and direct experience with GLP and/or GCLP standards.
• Experience in customer-facing, technical support, or consultative roles.

Benefits

• Medical, dental, and vision coverage with prescription benefits.
• 401(k) plan with company matching.
• Paid vacation, sick leave, holidays, and parental leave.
• Company-paid short-term and long-term disability insurance.
• Employee assistance program and various voluntary perks including fitness club contributions and pet insurance.

About the Company

Meso Scale Diagnostics (MSD) is a leader in providing advanced technologies for the development of sensitive and specific assays. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity.