Principal Specialist: Study Management

Departmental Objective
To efficiently conduct research in compliance with the Quality Management System, the Animal Care and Use Program, project budgets, and timelines
To expand and improve the site research activities through innovation, development, and customer focus.

Primary Job Purpose
Serve as lead support to a Principal Specialist: Study Management as needed on studies. This position is responsible for monitoring animal health status, performing and coordinating study events, and reviewing and approving study documentation as necessary throughout the study. This position will have group leader responsibilities, assist other study investigators, and support staff as required.

Job Specific Duties and Responsibilities
• Overall responsibility for the protocol development, technical conduct, and organizational aspects (start –finish) of GCP studies
• Preparing, reviewing and approval of Sponsor clinical study protocols and data capture forms (DCFs)
• Preparing study specific Clinvet IACUC protocols and IBC assessment
• Organizing/coordinating pre-study meetings 
• Providing technical directions and guidance to each study participants in responsibilities and 
accountabilities
• Participating key clinical activities (such as pre-study room/pen walk-through, arrival infections, IVP administration, challenge, necropsy)
• Providing study protocol and DFC training, critical disease training, Biosafety -Biosecurity-zoonotic disease biosecurity trainings as required
• Ensuring effective communication with the Sponsor, QA, and other test sites/sub‑contractors during the conduct of the study
• Collaborating with RTI Laboratory to ensure timely submission of quality clinical samples and timely completion of laboratory tests and inventory of retention samples per study protocol
• Collaborating with ClinData team to ensure timely delivery of DCFs for data Entry and analysis per study protocol
• Assisting/hosting regulatory and sponsor inspections/audit and addressing regulatory inspection and QA audit findings including plan of actions/corrections
• Prepare/review/Update clinical SOPs
• Establishing professional network to support business development

 Qualification, Training and Experience Requirements
• PhD or MSc in life sciences or
• Licensed Doctor of Veterinary Medicine (DVM) or
• Post-secondary university degree in life sciences (e.g., BSc) and at least 5 years hands-on clinical animal research experience