Study Support Specialist - GLP studies, Product Safety Labs

Job Description

Position Summary:

To better support the Study Director function and allow them to focus on scientific oversight and regulatory accountability.

Essential Duties and Responsibilities: 

• Collaborate with lab staff to gather study requirements, test article information, and study design details necessary for study initiation, laboratory assignment, and resource planning.
• Conduct quality control reviews of laboratory data, worksheets, and study records to ensure accuracy, completeness, consistency, and readiness for Study Director review  which will include long-term and complex studies generating extensive datasets.
• Monitor study milestones, deliverables, and critical path activities to proactively identify risks, communicate potential delays, and support on-time completion of client commitments and regulatory deadlines.
• Coordinate the development, review, revision, and issuance of study protocols, amendments, and associated study documentation in accordance with GLP requirements and internal procedures.
• Maintain study documentation and tracking systems, ensuring study files remain audit-ready and compliant with applicable quality standards throughout the study lifecycle.
• Assist with the preparation of shipping documentation and return authorizations for test articles, samples, and retained materials, while obtaining, reviewing, and maintaining chain-of-custody records and shipment tracking information.
• Support Study Directors with scheduling, study logistics, sample management, and cross-functional communication among laboratory, quality assurance, and/or project management.
• Track study-related actions, deviations, data requests, and outstanding documentation to ensure timely resolution and complete study records.
• Assist with the compilation, review, and organization of study data packages for report generation, archival, and regulatory inspection readiness.
• Provide technical writing support for projects which may include generating shell documents and tables of data that was collected over the course of a study.
• Trend study control performance and study outcome.
• Review study data to ensure activities were executed according to protocol requirements, SOP, approved timelines, and GLP expectations.

Qualifications

Basic Minimum Qualifications (BMQ): 

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

Education/Experience (BMQ):

Master’s degree in a science-related (Pharmacology / Toxicology would be a best fit) field with 5-7 years of experience in Pre-clinical studies / trials, IND enabling studies, IND filing and with knowledge of regulatory requirements (GLP).

Additional Information

Abilities and/or Skills:

• Honest, Dependable, Demonstrated Ability to Self-Manage
• Detail Oriented, Accurate, Precise
• Strong Math Skills
• Strong Organizational Skills
• Logical Thinking, Good Reasoning Ability
• Strong communication including verbal, writing, and presentation skills
• Dedication to quality, ethics, and customer service
• Ability to handle personal stress
• Mental and emotional stability and maturity
• Motivation to excel
• Should able to sit for long periods as per role requirement