Key Responsibilities and Required Skills for a Toxicology Coordinator

🎯 Role Definition

The Toxicology Coordinator plays a pivotal role in the non-clinical development of new chemical entities, pharmaceuticals, or biologics. Acting as a central hub for toxicology programs, this individual provides essential operational and logistical support for preclinical safety and toxicity studies. They serve as a critical link between internal project teams, scientists, and external partners like Contract Research Organizations (CROs). The primary objective of the Toxicology Coordinator is to ensure the smooth execution of studies, maintain impeccable documentation, and guarantee that all activities adhere to Good Laboratory Practice (GLP) and other global regulatory standards. This position is fundamental to generating the high-quality safety data required for regulatory submissions and advancing promising compounds through the development pipeline.

📈 Career Progression

Typical Career Path

Entry Point From:

Research Associate (in a related discipline like biology, pharmacology, or toxicology)
Laboratory Technician with experience in a regulated (GLP/GCP) environment
Associate Scientist from a CRO or pharmaceutical company

Advancement To:

Senior Toxicology Coordinator / Toxicology Study Manager
Associate Toxicologist / Scientist
Non-clinical Project Manager

Lateral Moves:

Regulatory Affairs Associate
Clinical Operations Coordinator

Core Responsibilities

Primary Functions

Coordinate and monitor the progress of outsourced non-clinical toxicology, safety pharmacology, and ADME studies conducted at Contract Research Organizations (CROs).
Serve as a primary operational point of contact for CROs, facilitating seamless communication, coordinating study activities, and proactively resolving logistical issues to ensure project milestones are met on time and within budget.
Manage the end-to-end lifecycle of study documentation, including the review of study protocols, amendments, and final reports for scientific accuracy, clarity, and compliance with GLP and other regulatory guidelines.
Oversee the timely shipment and logistics of test articles, reference compounds, and biological samples to and from testing facilities, ensuring proper documentation and adherence to shipping regulations.
Establish and meticulously maintain comprehensive study files and tracking systems, ensuring all critical documents (e.g., contracts, protocols, reports, correspondence) are archived and readily accessible for internal review or regulatory inspection.
Facilitate the internal review and approval process for all study-related documents, coordinating feedback from cross-functional stakeholders such as toxicologists, pathologists, and regulatory affairs specialists.
Track key study milestones, timelines, and deliverables, providing regular status updates to internal project teams and management to ensure alignment with overall program goals.
Assist in the preparation and quality control (QC) of non-clinical sections of regulatory submissions, including Investigational New Drug (IND), New Drug Application (NDA), and other global filings.
Actively monitor studies to ensure they are conducted in strict accordance with Good Laboratory Practice (GLP) regulations, internal SOPs, and international guidelines (e.g., ICH, FDA, EMA).
Coordinate financial aspects of outsourced studies, including obtaining quotes, processing invoices, and tracking study expenditures against approved budgets in collaboration with the finance department.
Schedule and organize key study-related meetings, such as kick-off meetings and data reviews, and are responsible for preparing agendas and documenting meeting minutes and action items.
Manage the archival of wet tissues, slides, blocks, and other physical study materials at the conclusion of a study, maintaining an accurate inventory.
Support toxicologists and study directors in the scientific and technical conduct of studies by gathering necessary information and facilitating data interpretation discussions.
Develop and maintain positive, collaborative relationships with CRO partners to foster a productive and efficient working environment.
Assist in the qualification and selection process for new CROs, including participating in site audits and evaluating their capabilities and quality systems.
Maintain and manage the non-clinical study database or information management system, ensuring data integrity and accuracy for all registered studies.
Review and reconcile CRO invoices against study contracts and work orders, identifying and resolving any discrepancies in a timely manner.
Prepare and distribute summary tables and presentations of study progress and key findings for internal team meetings and project reviews.
Contribute to the development and revision of internal Standard Operating Procedures (SOPs) related to the conduct and oversight of non-clinical studies.
Liaise with internal quality assurance (QA) units to schedule and facilitate audits of study protocols, in-life phases, data, and final reports.
Track and manage the non-clinical study schedule and its integration into the overall project development plan using project management tools.

Secondary Functions

Support the non-clinical toxicology team with literature searches and the compilation of background information on specific compounds or mechanisms.
Contribute to continuous improvement initiatives by identifying and suggesting enhancements to study coordination processes and workflows.
Assist in the preparation and forecasting of the annual non-clinical study budget by providing data on upcoming study costs.
Participate in cross-functional team meetings, representing the non-clinical operations function and providing updates on study logistics and timelines.

Required Skills & Competencies

Hard Skills (Technical)

Proficiency in understanding and applying Good Laboratory Practice (GLP) regulations (e.g., 21 CFR Part 58) and other international regulatory guidelines (ICH, OECD).
Experience with non-clinical study coordination and monitoring at Contract Research Organizations (CROs).
Ability to critically review scientific documents, including study protocols and toxicology reports, for accuracy and completeness.
Strong project management skills, with the ability to manage multiple studies, timelines, and deliverables simultaneously.
Familiarity with the drug development process, particularly the role of non-clinical safety assessment.
Competency with standard office software (Microsoft Office Suite, especially Excel and Word) and project management tools (e.g., MS Project, Smartsheet).
Knowledge of scientific terminology related to toxicology, pharmacology, and biology.
Experience with electronic document management systems (EDMS) and study information databases.

Soft Skills

Exceptional organizational skills and meticulous attention to detail are paramount for managing complex study documentation and timelines.
Excellent written and verbal communication skills for effective collaboration with internal teams and external CRO partners.
Strong interpersonal skills and the ability to build and maintain professional relationships with a diverse range of stakeholders.
Proactive problem-solving abilities to anticipate and address logistical and operational challenges.
Ability to work both independently with minimal supervision and as a collaborative member of a cross-functional team.
High degree of flexibility and adaptability to manage shifting priorities in a fast-paced R&D environment.
A strong sense of urgency and commitment to quality and project deadlines.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree (B.S./B.A.) in a relevant scientific discipline.

Preferred Education:

Master's degree (M.S.) in a relevant scientific discipline.

Relevant Fields of Study:

Toxicology
Pharmacology
Biology / Biomedical Sciences
Chemistry

Experience Requirements

Typical Experience Range:

2-5 years of relevant experience in a pharmaceutical, biotechnology, or Contract Research Organization (CRO) environment.

Preferred:

Direct experience in a role involving the coordination, monitoring, or management of non-clinical, GLP-regulated toxicology studies is highly preferred.