Study Coordinator

Inotiv•Boulder, CO

2d•Onsite

About The Position

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.

Requirements

Bachelor's degree in life sciences or other directly related field or degree with comparable coursework
A minimum of three years in a relevant pharmaceutical setting
A minimum of one year experience with animals and animal handling
A working knowledge and awareness of general laboratory procedures
Customer focused, results driven, communicative, and collaborative enabling effective customer satisfaction, including problem solving, fostering positive relationships, and proactive communication
Ability to adhere to and manage in accordance with the Code of Federal Regulations procedures
Experience in the use of computer software applications (e.g., Word, Outlook, Excel)
Possess strong skills for editing the format, style and language of draft protocols, spreadsheets and reports
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
Ability to read, write, speak, and understand English
Able and willing to work a flexible schedule according to study needs

Responsibilities

Follow all SOPs and other applicable company policies and procedures
Maintain confidential information
Interact and communicate with clients, vendors, other employees, and the community in a professional manner
Support and participate in company initiatives as directed
Maintain thorough knowledge of facility SOPs, policies, protocols, etc.
Adhere to all safety regulations and procedures
Provide assistance or support to other Inotiv sites as necessary
Perform other duties as assigned
Maintain and submit study initiation materials
Order all applicable supplies for studies
Communicate with other coordinators to schedule study activities
Ensure creation of data sheets
Confirm laboratory math for test article and disease induction formulation
Communicate with formulations team 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 USDA, AAALAC, OLAW, GLPs 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 study 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