Study Coordinator at INOTIV BOULDER LLC — Westminster, CO

Responsibilities and Duties

Corporate

• Follow all SOPs and other applicable company policies and procedures
• Maintain confidential information

General

• 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

Specific

• 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
• Perform other duties as assigned

Position Requirements

Education and experience

• At a minimum, the Study Coordinator must have a Bachelor's degree in life sciences or other directly related field or degree with comparable coursework and a minimum of three years in a relevant pharmaceutical setting
• The Study Coordinator must have a minimum of one year experience with animals and animal handling

Skills and abilities

• 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

Performance Requirements

General

• Ability to read, write, speak, and understand English
• Able and willing to work a flexible schedule according to study needs

Physical activity

• Moderate physical activity:
• Prolonged periods of sitting at a desk and working on a computer
• May occasionally lift and/or move objects
• Able to wear PPE (Personal Protection Equipment) as required

Working Conditions

• Work is normally performed in a typical interior office or laboratory environment
• Work may require use of PPE due to exposure to potentially dangerous materials and situations
• Noise level is usually moderate as commensurate with a typical office environment