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Job Summary: The Study Coordinator reports to the Study Coordinator Supervisor within the In Vivo Department with responsibilities centered around supporting all functions of the preclinical study process. The ability to…
Skills: Animal Handling, Preclinical Study Coordination, GLP Compliance, Technical Writing, Microsoft Office
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Colorado Springs, Colorado, United States · Hybrid
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Idaho Springs, Colorado, United States · On-site
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Englewood, Colorado, United States · On-site
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Denver, Colorado, United States · On-site
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Denver, Colorado, United States · On-site
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Denver, Colorado, United States · On-site
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Aurora, Colorado, United States · On-site
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Supports all functions of the preclinical study process, including maintaining study initiation materials and coordinating activities between stakeholders. Responsible for ensuring compliance with GLP and other regulations while performing quality checks on protocols and reports.
Requires a Bachelor's degree in life sciences or a related field with at least 3 years of pharmaceutical experience. Must have one year of animal handling experience and strong skills in technical editing and communication.
The Study Coordinator reports to the Study Coordinator Supervisor within the In Vivo Department with responsibilities centered around supporting all functions of the preclinical study process. The ability to communicate succinctly with clients, study directors and technicians is key as is a cross-functional, flexible, and collaborative spirit.
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
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 compliance with all policies and procedures
Ensure compliance with GLPs, 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
Qualifications/Education:
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)
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
Salary Range: $27- $34 per 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
Hybrid options potentially available after 4 months of employment based on business needs
Able to work overtime, as needed
#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.
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.
WHERE INSIGHTS LEAD TO ANSWERS Expect More In choosing a partner for discovery, development and research models, expect more: more attention, more insight, and a superlative experience. You’ve worked hard to get this far, and you deserve a provider seamlessly aligned to your needs and goals. Through scientific leadership and ongoing investments, Inotiv delivers a comprehensive range of services and products that will exceed your expectations. Benefit from our long and impeccable regulatory history, world class team of scientists, and track record of providing attentive, decisive service. Answering the right questions on time and with high-quality data is the key to achieving your objectives. At Inotiv, that is our focus: to provide you with both the broad scope and right-size solutions essential to your success. Gain the insights you deserve to get the answers you need. Expect more — with Inotiv. Inotiv is a Top Workplaces 2023 Winner.
Offices: 2701 Kent Ave., West Lafayette, IN 47906, US
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