Study Coordinator I

Study Coordinator

Position Responsibilities:

• Assists the scientists/associate scientists in performing project-related activities. Identify and/or resolve issues with studying raw data appropriately with the relevant staff. Collect and process the data and compile the bioanalytical reports.
• Perform quality review of study-related materials, forms, data tables, reports, and study-supporting documentation according to SOPs, GLP guidelines, laboratory policies, and client specifications.
• Identify issues and deviations from SOPs affecting the study-related data quality and communicate these with the appropriate management.

• Assure all runs are performed and QC and QA findings, including QC review data summary tables from Watson LIMS and various Excel spreadsheet formats, are responded to on time and are complete and accurate to meet client timelines.
• Attend client conference calls and prepare and provide agenda and meeting minutes when required. 
• Responsible for the processing of bioanalytical data accumulated during the development, validation, and production phases of quantitative and qualitative analytical procedures.
• Responsible for writing, editing, controlling, and tracking study protocols and lab data presented accurately and clearly in the final reports, revisions and amendments to study documentation and lab records.
• Must be skilled in scientific writing and editing and understand the Biotherapeutic services’ scientific observations, concepts, methodologies, and applications related to immunochemistry (e.g., PK/PD studies, biomarkers analysis and immunogenicity assessments), flow cytometry immunophenotyping, pharmacogenomic testing, and gene & cell therapy research, ensuring they meet the acceptance criteria and industry standards.
• Monitor the Biotherapeutics department’s performance daily in the reporting process including tracking deadlines, on-time delivery, and document error rate metrics to improve work efficiency. Coordinate and plan to work within the study team to meet deadlines. Obtain and transfer signed study reports to the appropriate personnel and communicate daily with other departments to resolve outstanding issues.
• Assist preparing, reviewing and compiling study-related and regulatory documents, including SOPs and investigation reports, relevant to the specific study area.
• Track the status of laboratory testing/assays and update Excel study tracking files and Smartsheet forms.
• Keep tracking developments in bioanalytical analysis fields, which may significantly impact the group’s functioning.
• Assist or perform other job duties as assigned.
• Attend continuing education courses or webinars, as appropriate.

Corporate Responsibilities:

• Adherence to laboratory health and safety procedures.
• Adherence to Standard Operating Procedures (SOPs).
• Adherence to applicable company policies and guidelines.
• Adherence to federal and/or local regulations, as applicable.

• A Bachelor’s degree in a scientific discipline (i.e., biological sciences, Chemistry, etc.) or equivalent experience is preferred, with a minimum of a year in a QC/QA role at a GLP/GMP facility and/or a minimum of a year in an analytical/bioanalytical laboratory environment, preferably within a CRO industry, that is under GLP regulation. Must be familiar with all GLP requirements (including auditing).
• Immunochemistry knowledge and experience are required.
• Knowledge of lab operations, and Toxicology testing guidelines.
• Functional knowledge of Watson LIMS is a plus.   
• Must have a sufficient scientific background to understand scientific concepts of ligand binding assays (biomarkers, PK, PD, immunogenicity, flow cytometry and cell-based assays).
• Must be detailed oriented, well organized with excellent interpersonal and verbal/written communication skills with the ability to interact with the management, scientific and operations personnel.
• Extremely strong competence using Microsoft Word and Excel especially with various formatting features. 
• Must be detail oriented, well organized with exceptional communication skills.
• Self-motivated and willing to accept responsibility and challenges, learn new skills, and grow with the company.

*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 for this role is $55,000-63,000.  The salary could 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.  The salary range estimated for this position is $60,600 to $72,700. 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.

Inotiv has been named a 2023 Top Workplace!

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.

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