Study Coordinator I

The Study Coordinator will be responsible for supporting all functions of the non-clinical study process. The Study Coordinator will work as part of a team conducting routine procedures required for study conduct; interacting and communicating with clients, study directors, and technicians in a cross-functional, flexible, and collaborative spirit.

• 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
• Maintain and submit study initiation materials
• Communicate effectively with all key stakeholders including vendors and clients
• Order all applicable supplies for studies
• Communicate with other coordinators to schedule study activities
• Insure creation of data sheets
• Confirm lab math for test article and disease induction formulation
• Communicate with formulation department regarding timeline and materials needed
• Assist with in-life study conduct, as needed, and as trained
• Complete training requirements as assigned and maintain appropriate training documentation
• Maintain compliance with all policies and procedures
• Ensure compliance with USDA, AAALAC, OLAW and other applicable regulations
• Perform quality checks, reviews, and formatting on all Inotiv documents (e.g., protocols, amendments, deviations, reports, tables, etc.)
• Develop and maintain protocol, report, and data table master templates
• Provide back-up support for Study Directors as needed
• Aid in protocol and any protocol amendment or deviation preparation and distribution
• Prepare and review raw data collection forms and review for adherence to protocol, both prior to study start and after study completion
• Review raw data collection and in-life study conduct
• Assist to prepare a complete study file for archival following finalization of report
• Assist to ensure that study samples and test articles are shipped appropriately, on schedule, and documented in the study file
• Perform other duties as assigned

Position Requirements

Education and experience

• Bachelor's degree in life sciences or other directly related field or degree with comparable coursework and a minimum of 3 years in a relevant pharmaceutical setting
• One year animal handling experience required
• Possess strong skills for editing the format, style and language of draft protocols, spreadsheets and reports
• Experience using Microsoft Office (Word, Excel, Outlook), Pristima or Provantis experience a plus

Skills and abilities

• Individuals must demonstrate strong communication skills and be able to work efficiently in individual and team settings.
• Excellent written and verbal communication skills
• An attitude for quality, an eye for detail and the ability to read and follow written instructions
• Ability to interact with scientific staff at all levels

Performance Requirements

• Able to work overtime, as needed

*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. This is a non-exempt role paying $26-$31/hour.

*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.