Study Director III, Toxicology

BAS EVANSVILLE INC; Evansville (IN); Vor Ort; USD 70.000 - 90.000; Vollzeit

Benefits dieser Stelle

Health and dental coverage

Short‑ and long‑term disability

Paid time off

Paid parental leave

401(k)

More benefits as applicable

Zusammenfassung

BAS EVANSVILLE INC is seeking a Study Director to oversee protocol development, study coordination, and regulatory reporting. The role requires a Bachelor's degree and significant experience in laboratory settings.

Key responsibilities include managing study protocols, ensuring compliance with GLP regulations, and preparing reports. Candidates must possess strong organizational skills, knowledge of FDA guidelines, and a background in biological sciences.

Benefits include health coverage, paid time off, and a 401(k) plan.

Qualifikationen

• Bachelor’s degree and 10 years of relevant experience, or Master’s degree and 5 years of relevant experience.
• Knowledge of cGMP, GLP, GCP, and OECD regulations is required.
• Ability to document analytical results.

Aufgaben

• Responsible for all phases of protocol development and study coordination.
• Monitor study progress and report results to the sponsor.
• Maintain knowledge of FDA and other regulatory guidelines.

Kenntnisse

Good organizational skills

Ability to use a computer to compile and maintain databases

Knowledge of cGMP/GLP/GCP regulations

Good written and oral communication skills

Ability to work independently

Ausbildung

Bachelor's degree with 10 years of relevant experience

Master's degree with 5 years of relevant experience

Doctoral degree with at least 2 years of laboratory animal experience

Tools

Windows-based software applications (Excel, Word, PowerPoint)

Jobbeschreibung

Performance Requirements

• 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 periods 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 required
• Will be exposed to animal dander, bites, scratches, etc., and material associated with animal husbandry
• Ability to wear latex gloves, dust mask and/or respirator, and safety glasses as required
• The noise level is usually moderate to loud requiring ear protection
• Montoux 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 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, overseeing the production of protocol development, study coordination, and regulatory reporting while ensuring compliance with GLP, cGMP, GCP, and OECD regulations.

Position Requirements

• Education: Bachelor’s degree and 10years of relevant experience, or Master’s degree and 5years of relevant experience, or Doctoral degree in one of the biological sciences and at least 2years of relevant laboratory animal experience
• Salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level
• 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

Skills and Abilities

• Good organizational skills
• Ability to use a computer to compile and maintain databases for records and inventory, utilizing the appropriate software
• Knowledge and understanding of cGMP/GLP/GCP and OECD regulations, 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

Benefits

• Health and dental coverage
• Short‑ and long‑term disability
• Paid time off
• Paid parental leave
• 401(k)
• More benefits as applicable

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.