Study Coordinator

Responsibilities And DutiesCorporateFollow all SOPs and other applicable company policies and proceduresMaintain confidential informationGeneral Interact and communicate with clients, vendors, other employees, and the community in a professional mannerSupport and participate in company initiatives as directedMaintain thorough knowledge of facility SOPs, policies, protocols, etc.Adhere to all safety regulations and proceduresProvide assistance or support to other Inotiv sites as necessaryPerform other duties as assignedSpecificMaintain and submit study initiation materialsOrder all applicable supplies for studiesCommunicate with other coordinators to schedule study activitiesEnsure creation of data sheetsConfirm laboratory math for test article and disease induction formulationCommunicate with formulations team regarding timeline and materials neededAssist with in-life study conduct, as needed, and as trainedComplete training requirements as assigned and maintain appropriate training documentationPerform 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 neededMaintain compliance with all policies and proceduresEnsure compliance with USDA, AAALAC, OLAW, GLPs and other applicable regulationsPerform 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 templatesProvide back-up support for Study Directors as neededAid in protocol and any protocol amendment or deviation preparation and distributionPrepare and review raw data collection forms and review for adherence to protocol, both prior to study start and after study completionReview raw data collection and in-life study conductAssist to prepare a complete study file for archival following finalization of reportAssist to ensure that study samples and test articles are shipped appropriately, on schedule, and documented in the study filePerform other duties as assignedPosition RequirementsEducation and experienceAt 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 settingThe Study Coordinator must have a minimum of one year experience with animals and animal handlingSkills And AbilitiesA working knowledge and awareness of general laboratory proceduresCustomer focused, results driven, communicative, and collaborative enabling effective customer satisfaction, including problem solving, fostering positive relationships, and proactive communicationAbility to adhere to and manage in accordance with the Code of Federal Regulations proceduresExperience 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 reportsExcellent written and verbal communication skillsAn attitude for quality, an eye for detail and the ability to read and follow written instructionsAbility to interact with scientific staff at all levelsPerformance RequirementsGeneralAbility to read, write, speak, and understand EnglishAble and willing to work a flexible schedule according to study needsPhysical activityModerate physical activity:Prolonged periods of sitting at a desk and working on a computerMay occasionally lift and/or move objectsAble to wear PPE (Personal Protection Equipment) as requiredWorking ConditionsWork is normally performed in a typical interior office or laboratory environmentWork may require use of PPE due to exposure to potentially dangerous materials and situationsNoise level is usually moderate as commensurate with a typical office environmentThis 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.