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Study Coordinator

Inotiv
parental leave, paid time off, 401(k)
United States, Texas, Alice
Jul 03, 2025
The Study Coordinator in Alice, Texas will support the planning, execution, and documentation of preclinical studies, ensuring compliance with study protocols, regulatory requirements, and internal standards. This role collaborates closely with cross-functional teams, including veterinary, husbandry, and research staff, to manage study timelines, track data, and maintain accurate records. The ideal candidate is detail-oriented, organized, and capable of coordinating multiple studies in a fast-paced research environment.
  • Function as the liaison between Study Directors and In-Life technical staff to ensure proper conduct of all study activities.
  • Enter and/or review all appropriate protocol details for in-life studies in the study documentation /electronic data capture system.
  • Maintain study animal use details and manage study colony inventory for various study assignments; i.e. monitor test article exposure (e. g. biologics or small molecule) wash-out periods and animal health (physical exams or clin path testing)
  • Work with management to determine available animals for use when the study design requires naive animals (inventory).
  • Assist the Study Director with writing the study draft protocols and the IACUC Animal Use Protocol.
  • Participate in pre-study meetings with Study Directors, Sponsors, In-Life Management and additional In-Life staff members as appropriate.
  • Assist the Study Director with coordinating and aligning departments regarding resource availability, scheduling, etc., prior to initiation of all study activities (animal, lab and shipping procedures) and periodically during the project as needed
  • Collate and disseminate study initiation materials
  • Create and implement temporary and permanent animal identification cards/tags for each study.
  • Set up study notebook with Animal Use Protocol, study protocol, EHS protocol, and relevant forms and ensure it is maintained with all required study documents for the duration of the study and that it is finalized at study completion.
  • Responsible for all study preparation activities (i.e., selection of appropriate animals, animal housing/acclimation, all required supplies are available and labeled, etc.).
  • Create and/or review & approve data collection forms, specific data sheets such as timed dosing spreadsheets, formulation instructions, and formulation labels.
  • Ensure that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
  • Clearly and accurately document study activities following Inotiv requirements for written and electronic data recording and data integrity.
  • Ensure that any unexpected events that may affect the quality and integrity of the study are noted when they occur, management/Study Director is informed, and corrective action is taken and documented.
  • Accurately perform basic laboratory calculations and measurements
  • Assist the Study Director with any protocol amendment or deviation preparation and distribution
  • Ensure that study samples and test materials are shipped appropriately, on schedule, and documented in the study file
  • Conduct quality control review of facility records, study documentation, and in-life reports (e.g., in life forms, formulation sheets, study notebook).
  • Perform periodic review of all applicable SOPs to ensure accuracy and confirm procedures are being performed according to SOPs. Participate in SOP writing, reviews, and revisions, as needed
  • 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.
  • Excellent organizational skills
  • Good written and oral communication skills with a professional and positive attitude.
  • Experience with Word and Excel required. Experience with SAS, Provantis, and SmartSheet are a plus.
  • Demonstrate an understanding of facility SOPs and Good Laboratory Practice Regulations (21CFR, Part 58) as they relate to study specific services provided, this job description and general facility operations.
  • Working knowledge and awareness of general laboratory procedures
  • Be familiar with and monitor routine animal study activities including animal identification, clinical observations, restraint, animal randomization, test article administration (including but not limited to gavage, dermal applications, IV, IP, and subQ), specimen collections, and appropriate conduct (PPE and other safeguards) to avoid cross-contamination between samples and experiments.
  • Customer Focus. Identifies, prioritizes and anticipates customer needs and delivers relevant, value-add, solutions to meet and exceed them
  • Results Driven. Internal drive toward action to efficiently, timely, and accurately achieve results. Sets high but achievable standards for self and others. Seeks opportunities to improve process and outcomes. Constantly reviews performance to identify areas to develop.
  • Efficient. Takes responsibility for own time and effectiveness. Identifies what needs to be done and does it before being asked or before the situation requires it. Able to work things out without having to be shown too often. Seeks opportunities to contribute appropriately without direction.
  • Communication. Able to communicate information and ideas clearly and articulately both in oral and written form. Uses appropriate language, style and methods depending on audience and the purpose of communication. Able to convey complex information clearly. Anticipates the information that others will need. Expresses ideas effectively. Practices attentive and active listening.
  • Collaboration. Actively supports and contributes to the success of the team. Actively encourages and practices collaboration and cooperation on the team. Shares information and supports other team members. Can get things done with and through others and set realistic objectives. Seeks opportunities to develop others.
  • Relationship Builder. Develops, maintains, and strengthens strong partnerships with others internally and externally, cross functionally, in person and remotely.
  • Critical Thinking and Problem Solving. Able to identify and separate out the key components of problems and situations. Able to manipulate and interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this. Can generate a range of creative solutions, evaluate, and choose the most appropriate option
  • Improvement Driven. Inspires and generates new solutions and approaches to issues and challenges to maximize efficiency and effectiveness through everyday practice of root cause analysis and critical thinking problem solving; Continually works to refine skills and abilities; Builds on ideas of others to come up with new ways to address issues or problems; Generates creative new solutions and approaches to issues and processes.
  • Organization and time Management. Plans and prioritizes work, manages time appropriately to meet deadlines, follows up with others to ensure one's own work and commitments are completed on time, deals with pressure and deadlines through good planning.
  • B.A./B.S. degree in Biology or related scientific field preferred
  • 3 years of direct laboratory experience at a minimum

*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.

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

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!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.

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