Study Coordinator

About the role

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.

• Assist with training of technicians and coordinators
• 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
• Request order of all applicable supplies for studies
• Communicate with management to schedule study activities
• Insure creation of data sheets
• Confirm lab math for test article and disease induction formulation
• Assist with in-life study conduct, as needed, and as trained, including surgery and advanced techniques
• 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
• Perform data analysis
• Assist to prepare a complete study file for archival following finalization of report
• Ensure that study samples and test articles are shipped appropriately, on schedule, and documented in the study file
• Perform other duties as assigned

Education and experience

• Doctorate degree in life sciences or other directly related field or degree with comparable coursework and a minimum of 2 years in a relevant pharmaceutical setting
• Master's degree in life sciences or other directly related field or degree with comparable coursework and a minimum of 5 years in a relevant pharmaceutical setting
• Bachelor's degree in life sciences or other directly related field or degree with comparable coursework and a minimum of 8 years in a relevant pharmaceutical setting
• Possess strong skills for data analysis and editing the format, style and language of draft protocols, spreadsheets, and reports
• Experience using Microsoft Office (Word, Excel, Outlook) and Prism

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

Salary Range

$26-$31per hour, adjusted according to the level of the role and the candidate's relevant experience and/or education. Salary will be commensurate with experience and responsibilities.

Benefits

• Health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401(k), and more.
• Position Status: Open until filled.
• #LI-JM1
• #LI-Onsite

*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.

At Inotiv, our work helps advance the development of new medicines and therapies that can improve people's lives. As a leading global contract research organization (CRO), we partner with researchers to tackle complex scientific challenges, drive innovation, and help build a healthier, safer world.

Bringing together scientists, researchers, technical experts, and business professionals, we provide the expertise and collaboration needed to move research forward. Our people make this work possible, and we value the knowledge, ideas, and contributions each person brings to the team.

• Whether you are starting your career or bringing years of experience, Inotiv offers opportunities to learn, grow, and play a meaningful role in advancing treatments for patients around 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!