Study Coordinator

Inotiv, Inc.; Boulder (CO); On-site; USD 36,000 - 43,000; Full time

Benefits offered by this job

Health and dental coverage

Short- and long-term disability

Paid time off

Paid parental leave

401(k)

Job summary

Inotiv, Inc. in Boulder, CO is seeking a Study Coordinator to support the preclinical study process on-site. You will communicate with study directors, technicians, and vendors, manage initiation materials, and ensure compliance with GLPs, USDA, AAALAC and OLAW.

The role emphasizes data integrity, SOP adherence, and collaborative work across departments. Responsibilities include preparing data sheets, protocol amendments, and back-up support for Study Directors, with attention to detail and

Qualifications

• Bachelor's degree in life sciences or related field with minimum 3 years in a pharmaceutical setting.
• Strong written and verbal communication skills.
• Excellent data management and ability to edit protocols, spreadsheets and reports.

Responsibilities

• Maintain and submit study initiation materials.
• Communicate with vendors, clients and stakeholders.
• Order supplies for studies and schedule activities.
• Ensure data sheets and lab math accuracy.
• Assist in in-life study conduct and training requirements.
• Ensure SOP compliance and participate in SOP revisions.

Skills

Communication

Editing documents

Microsoft Office

Attention to detail

Team collaboration

Education

Bachelor's degree in life sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

## Study CoordinatorApply: On-site: Boulder, CO (E): Full time: Posted Yesterday: JR101838**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/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 levelsSalary 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: Health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401(k), and more.Position Status: Open until filled.