Study Coordinator

INOTIV BOULDER LLC; Boulder (CO); On-site; USD 36,000 - 43,000; Full time

Benefits offered by this job

Health and dental coverage

401(k) plan

Paid time off

Parental leave

Job summary

Inotiv is seeking a Study Coordinator to support all functions of the preclinical study process. You will communicate with clients, study directors, and technicians, and work in a cross-functional, collaborative team to ensure study timelines and data integrity.

Key duties include submitting materials, coordinating with vendors, maintaining study files, ensuring GLP and regulatory compliance, and assisting with in-life study conduct.

Qualifications

• Bachelor's degree in life sciences or related field; minimum 3 years in a relevant pharmaceutical setting
• One year of animal handling experience required
• 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
• Ability to interact with scientific staff at all levels

Responsibilities

• Maintain and submit study initiation materials
• Communicate with key stakeholders including vendors and clients
• Order supplies for studies
• Coordinate study activities with other coordinators
• Ensure creation of data sheets
• Confirm lab math for test article and disease induction formulation
• Coordinate with formulation department on timelines/materials
• Assist with in-life study conduct as trained
• Complete training requirements and maintain documentation
• Review SOPs to ensure accuracy and conformity
• Participate in SOP writing, reviews and revisions
• 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 Inotiv documents
• Develop and maintain protocol, report, and data table templates
• Provide back-up support for Study Directors
• Aid in protocol/amendment/deviation preparation and distribution
• Prepare and review raw data collection forms for adherence to protocol
• Review raw data collection and in-life study conduct
• Assist to prepare a complete study file for archival
• Assist to ensure study samples and test articles are shipped on schedule and documented
• Perform other duties as assigned

Skills

Editing protocols/reports

Microsoft Office

Written & verbal communication

Attention to detail

Education

Bachelor's degree in life sciences or related field

Tools

Microsoft Office Suite

Job description

Job Summary

The Study Coordinator reports to the Study Coordinator Supervisor 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.

Responsibilities

• 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
• Ensure 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 and 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

Salary Range: $26- $31 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

• Benefits: Health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401(k), and more.
• Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, 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! 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. At Inotiv, our people are our greatest asset. We are committed to equality, opportunity, and diversity, and treating our colleagues with the dignity and respect they deserve. We strive to ensure that our people achieve their full potential, and that they enjoy a rewarding career with us.

We’re looking for people who will help us grow and support our shared purpose: to help our clients discover and develop life-changing therapies for people around the world. As a leading contract research organization (CRO), Inotiv supports discovery and nonclinical development through investigational new drug (IND) and beyond. By leveraging our deep expertise and scientific capabilities, we help you increase efficiency, improve data, and reduce the cost of taking new drugs to market. By providing critical research models and related services, we help researchers realize the full potential of their R&D projects, all while working together to build a healthier and safer world. We hope you consider our opportunities and a future with Inotiv!