Study Director I

General Summary:

The Study Director (SD) will engage in serving as the single point of study control and is responsible for overall planning and conduct of the non-clinical investigations in accordance with applicable regulatory guidelines and contemporary scientific practice. Additionally, the SD will ensure that all Good Laboratory Practices (GLP) are met, and that the outcome of the study is valid and reliable.

This is an exempt role that is not eligible for overtime and has no supervisory responsibility.

Primary Responsibilities and Competencies:

**Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Team Study Support:

• Provide support to protocol development, amendments, and deviation writing, and contribute to the preparation of study draft reports by performing accurate data entry, cross-checking source data, and verifying data integrity in compliance with study protocols and institutional SOPs.
• Provide support to the development, revision, and pre-QA review of study worksheets, ensuring data accuracy, protocol alignment, and readiness for Quality Assurance (QA) final review.
• Order special supplies or products that are study specific.

For Assigned Studies:

• Represent the single point of control for all aspects of a study while serving as Study Director for non-clinical studies.
• Responsible for the technical conduct of the study as well as for the interpretation, analysis, documentation, and reporting of results.
• Generate protocol and ensure that the protocol, including any changes/amendments, are approved and followed.
• Ensure all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
• Ensure that unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
• Ensure that Test systems are as specified in the protocol.
• Ensure compliance with protocol, amendments, regulatory agencies as identified in the protocol, and SOPs.
• Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of a study.
• Interface with Sponsors, Vendors, Contributing Scientists and Principal Investigators.

*Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time.

Role Requirements

• Master’s Degree or equivalent in a related discipline required
• 5 years of experience in a GLP-compliant laboratory preferred
• Experience with peer reviewed publications, presentations, scientific writing
• Proficiency with Microsoft Office core applications and the ability to learn and use additional applications
• Good written and oral communication skills
• Knowledge of GLPs (FDA) and other federal regulations relating to care of laboratory animals
• Strong understanding of study design and protocols
• Strong understanding of laboratory operations and data collection
• Ability to work under specific time constraints

Working Environment Requirements

• The person filling this position will spend approximately 90% in an office setting and 10% in the laboratory. There will be exposure to animal pathogens and chemicals. There will be handling of, and/or exposure to animal tissue and potential zoonotic organisms.
• Ability to don and wear personal protective gear, including N95 masks and respirators.
• Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended shifts and/or extra shifts, sometimes on short notice.

IBEX is committed to providing equal opportunities. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, nationality, ancestry, national origin, sex (including pregnancy), gender, affection or sexual orientation, gender identity or expression, age, familial status, marital status, domestic partnership or civil union status, veteran status, physical, sensory, or mental disability, perceived disability, AIDS and HIV status, atypical heredity cellular or blood trait, liability for service in the Armed Forces, genetic information or any other protected category under federal, state or local laws.

Job Type: Full-time

Pay: $75,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Relocation assistance
• Vision insurance

Work Location: In person