Study Coordinator

Responsibilities and Duties

Corporate

• Follow all SOPs and other applicable company policies and procedures

• Maintain confidential information

General

• Interact and communicate with clients, vendors, other employees, and the community in a professional manner

• Support and participate in company initiatives as directed

• Maintain thorough knowledge of facility SOPs, policies, protocols, etc.

• Adhere to all safety regulations and procedures

• Provide assistance or support to other Inotiv sites as necessary

• Perform other duties as assigned

Specific

• Maintain and submit study initiation materials

• Order all applicable supplies for studies

• Communicate with other coordinators to schedule study activities

• Ensure creation of data sheets

• Confirm laboratory math for test article and disease induction formulation

• Communicate with formulations team 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 USDA, AAALAC, OLAW, GLPs 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 study 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

Position Requirements

Education and experience

• At a minimum, the Study Coordinator must have a Bachelor's degree in life sciences or other directly related field or degree with comparable coursework and a minimum of three years in a relevant pharmaceutical setting

• The Study Coordinator must have a minimum of one year experience with animals and animal handling

Skills and abilities

• A working knowledge and awareness of general laboratory procedures

• Customer focused, results driven, communicative, and collaborative enabling effective customer satisfaction, including problem solving, fostering positive relationships, and proactive communication

• Ability to adhere to and manage in accordance with the Code of Federal Regulations procedures

• Experience in the use of computer software applications (e.g., Word, Outlook, Excel)

• Possess strong skills for editing the format, style and language of draft protocols, spreadsheets and reports

• 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

Performance Requirements

General

• Ability to read, write, speak, and understand English

• Able and willing to work a flexible schedule according to study needs

Physical activity

• Moderate physical activity:

  • Prolonged periods of sitting at a desk and working on a computer

  • May occasionally lift and/or move objects

• Able to wear PPE (Personal Protection Equipment) as required

Working Conditions

• Work is normally performed in a typical interior office or laboratory environment

• Work may require use of PPE due to exposure to potentially dangerous materials and situations

• Noise level is usually moderate as commensurate with a typical office environment

*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.

Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity.  Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.  There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen.  Join us in embracing research and science to impact the health and well-being of people all over 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.