Study Coordinator

BASI Gaithersburg LLC; Boulder (CO); On-site; USD 55,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

Disability insurance

Paid time off

Parental leave

401(k)

Job summary

Inotiv seeks a Study Coordinator in Boulder to support preclinical study processes and communicate with clients, study directors, and technicians.

You will maintain materials, coordinate activities with vendors, ensure data sheets, and assist in in-life study conduct while adhering to SOPs and GLP standards.

Salary will be commensurate with experience; benefits include health and dental coverage, disability, PTO, parental leave, 401(k), and more.

Qualifications

• Bachelor's degree in life sciences or related field required, with 3+ years in pharma setting.
• Animal handling experience required.
• Strong editing and formatting skills for protocols, spreadsheets, and reports.

Responsibilities

• Maintain and submit study initiation materials.
• Communicate with vendors and clients.
• Order supplies for studies.
• Coordinate study activities with other coordinators.
• Ensure creation of data sheets.
• Review SOPs to ensure accuracy and compliance with GLPs, USDA, AAALAC, OLAW.

Skills

Communication

Attention to detail

Interpersonal skills

Education

Bachelor's degree in life sciences or related field

3+ years in pharmaceutical setting

Animal handling experience

Tools

MS Word

Excel

Outlook

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/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

*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.