GLP STUDY COORDINATOR

Inside Higher Ed; Philadelphia (Philadelphia County); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading educational organization is seeking a GLP STUDY COORDINATOR to manage non-GLP and GLP preclinical studies involving animal models. The ideal candidate will have 3-5 years of experience in pharmaceutical research, strong technical lab skills, and knowledge of regulatory compliance. This full-time position requires excellent communication and organizational abilities in a fast-paced environment.

Qualifications

• 3-5 years of pharmaceutical/biotechnology experience in GLP studies.
• Solid technical lab skills and ability to maintain records.
• Knowledge of toxicology data generation and review.

Responsibilities

• Coordinate and schedule GLP studies involving animal models.
• Ensure compliance with FDA and GLP regulations.
• Track investigational materials and laboratory records.

Skills

GLP compliance

Technical lab skills

Effective communication

Data analysis

Problem-solving skills

Education

Bachelor’s degree in Chemistry, Biology, Biochemistry

Tools

Microsoft Office

Project management/database software

Job description

Overview

GLP STUDY COORDINATOR role at Inside Higher Ed

Responsibilities

• Coordinate and schedule non-GLP research and GLP preclinical in vivo studies involving rodent and large animal models, including non-human primates (NHP).
• Ensure practices comply with FDA, GLP and other applicable regulations and guidelines (USDA, OLAW, AALAC).
• Schedule activities for preclinical studies; communicate study updates, data and documents.
• Submit amendments and deviations within defined time frames to maintain data integrity and study quality.
• Track and store investigational materials and laboratory records; monitor project timelines and milestones for on-time delivery.
• Maintain study protocols, outlines, and in-life data; prepare final reports for IND filings and FDA submissions.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Biochemistry or related discipline.
• 3-5 years of pharmaceutical/biotechnology experience in preclinical pharmacology or toxicology testing conducted under Good Laboratory Practices (GLP; 21 CFR Part 58) or an equivalent combination of education and experience. Master’s degree preferred.
• Strong experience managing GLP animal studies; solid technical lab skills; ability to communicate effectively, maintain records, and analyze data.
• Knowledge of toxicology data generation/compilation/review; GLP toxicology; Microsoft Office; project management/database software experience is a plus.
• Highly organized, productive in a fast-paced environment with problem-solving and interpersonal skills.

Additional Details

• Reference Number: 40-29796
• Employment Type: Exempt
• Org: DM-Gene Therapy Program