This position is responsible for the execution of studies as assigned by in-life management including managing study resources, activities, and operations. This position will be responsible for all phases of protocol development, study conduct, data compilation & review, and reporting, and will interact and engage with study sponsors to ensure they receive timely communication throughout the life cycle of the project.
Essential Duties and Responsibilities- For potential and awarded studies, work with management to determine available animals for use (inventory) and that studies are appropriately resourced (personnel).
- Responsible for all phases of protocol development including approval prior to initiation of study activities.
- Establish appropriate communication mechanisms with the sponsor and ensure timely communication throughout the life cycle of the project.
- Review & approve data collection forms, formulation instructions, and formulation labels.
- Responsible for confirming that the study work schedule/calendar is consistent with study protocol.
- Manage the conduct of all study activities in alignment with the protocol and appropriate SOPs
- Assure that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
- Assure that any unexpected events (including SOP or protocol deviations) that may affect the quality and integrity of the study are noted when they occur, management is informed, and corrective action is taken and documented.
- Report study results to the Sponsor after consultation with senior staff and in collaboration with key personnel/principal investigators.
- Ensure that study data and specimens are compiled, organized, inventoried, and archived at Inotiv or transferred to the archiving facility/sponsor prior to or upon completion of the report.
- Ensure that studies requiring methods other than those normally used are brought to the attention of staff and that staff are appropriately trained.
- Assist with the optimization of the in-life study conduct operation at Alice, TX including the review and implementation of new workflow and study conduct processes as deemed necessary by in-life management.
- Available to work weekends, holidays, and extended hours during the work week as assigned.
- Competency in the use of relevant computer systems and capable of assisting others with troubleshooting activities.
- Compliance with applicable USDA regulations, Animal Welfare Act, facility Animal Care and Use Committee requirements, and the Guide for Care and Use of Laboratory Animals.
- Responsible for monitoring compliance with all facility and company safety requirements including full compliance of PPE use and all safety policies and procedures.
Education and Experience- Bachelor's in Science
- 3-5 years' experience In-vivo Study Execution or Study Direction Experience in Pharmacology, Pharmacokinetics, or Toxicology
*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.
Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!
