Bachelor's degree and 10 years or master's with 5 years, or PhD with 2 years in biological sciences.
Experience in laboratory animal work required.
Familiarity with cGMP, GLP, GCP, and OECD regulations.
Strong organizational skills and attention to detail.
Effective written and oral communication skills.
Responsibilities
Develop and oversee study protocols with team engagement.
Direct and supervise technical staff in compliance with standards.
Monitor study progress and report findings to sponsors.
Conduct literature searches to support project needs.
Assist in preparing scientific papers and presentations for publication.
Prepare interim reports based on study data in consultation with senior staff.
Ensure adherence to safety and regulatory practices.
Benefits
Health and dental coverage.
Short- and long-term disability options.
Paid time off and paid parental leave.
401K retirement plan options.
Full Job Description
Performance requirements
Characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
General
Ability to read, write, speak, and understand English
Ability to read, write and understand oral and/or written instructions
Physical Activity
Ability to read, write and interpret scientific material
Manual dexterity to perform research functions, type and use office equipment
Ability to stand or sit for long period of time
Working Conditions
Frequent involvement with radiant/electrical energy, solvents, grease, oil, irritants, acids, bases, and other hazardous chemicals, electro-mechanical hazards, flammable materials, and biohazards. Due to exposure to hazardous biological materials (which may include HIV positive specimens), immunization to diseases may be a required
Will be exposed to animal dander, bites, scratches, etc., and material associated with animal husbandry
Able to wear latex gloves, dust musk and/or respirator, and safety glasses as required.
The noise level is usually moderate to loud requiring ear protection
Mantoux TB test with negative result is required
Tools, Equipment, & Other Resources Used
Various software applications sustained by a WindowsTM platform. (Excel, Word, PowerPoint, etc.)
Responsibilities and Duties
Responsible for all phases of protocol development; communicating with supervisory staff to establish a study schedule, the sponsor to finalize the protocol and the technical staff to coordinate study initiation
Direct and/or supervise the work of technical staff in accordance with the GLP's
Monitor the progress of studies and after consultation with senior staff, report the results to the sponsor
Participate in in-house training programs for the technical staff
Conduct literature and/or Internet searches in support of protocol or report preparation
With the assistance of senior staff, prepare posters and/or scientific paper that will contribute to the scientific reputation of Inotiv Evansville and the individual
In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor
Maintain knowledge of FDA and other regulatory guidelines that may affect protocol development
Inform the management of any issues affecting the conduct of preclinical studies, interaction with clients and/or generation of protocols and reports
Perform other duties as assigned
Maintain confidential information
Interact with the community and employees
Support and participate in other company initiatives as directed by management
Position Summary
Perform duties of a Study Director
Position Requirements
Education and experience
This position requires a bachelor's degree and 10 years of relevant experience, or a master's degree and 5 years relevant experience, or a doctoral degree in one of the biological sciences and at least 2 years relevant laboratory animal experience
Skills and Abilities
Good organizational skills
Ability to use a computer to compile and maintain databases for records and inventory, utilizing the appropriate software
Know and understand cGMP/GLP/GCP and OECD regulations, as applicable, with the ability to apply these practices daily
Ability to work independently
Good written and oral communication skills
Ability to adhere to all safety regulations and procedures
Ability to document analytical results
*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.
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!
