Study Coordinator II
: Job Details :

Study Coordinator IILocation : LocationUS-MD-RockvilleID2024-5050CategoryResearch and ScienceTypeFull Time - PermanentOverview

Study Data Coordinator III

Responsibilities

Skills and abilities

* Knowledge of lab operations.

* 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 as well as experience with Gantt charts and Smartsheets.

* Experience in report writing and project management.

* Self-motivated and willing to accept responsibility and challenges, learn new skills, and grow with the company.

* Ability to multi-task and participate in multiple studies concurrently.

* Ability to ensure high quality data while working under the pressure of strict deadlines.

Physical Activity

* Moderate physical activity This position will require frequent walking, sitting and/or standing for extended periods of time, carrying, heavy lifting (max. 50 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions (for more than four [4] hours per day)

* Able to wear latex or nitrile gloves, dust mask or respirator, and safety glasses as required.

* Ability to read and understand applicable materials

* Manual dexterity to operate laboratory equipment and calculator/computer

* Able to read and interpret test results and instrument specifications

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.

General

* Assists the study team in performing project-related activities. Identify and/or resolve issues with studying raw data appropriately with the relevant staff.

* 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.

Specific

* Provide SME support for all functions related to study coordination and report writing in the team.

* Ensure the accurate, complete, and timely collection, delivery and tracking of bioanalytical information.

* Assist with project management and sponsor communication.

* Mentor and train junior staff in Data Coordination duties.

* 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.

* 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.

* Prepare study files for and assist with responses to QA audits.

* Prepare study files for archiving per SOP, GLP and client specifications.

* Communicate and collaborate across team to identify data discrepancies and resolve them.

* Review and respond to queries to address problematic data identified during the run/data review and apply proper correction or modification.

* 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.

* Understand the scientific observations, concepts, methodologies, and applications related to immunochemistry services (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.

Professional Responsibilities:

* Attend continuing education courses or webinars, as appropriate.

Qualifications

Education and experience:

At least a Bachelor's degree in a scientific discipline (i.e., biological sciences, Chemistry, etc.) or equivalent experience.
• Must have a minimum of three years in a QC/QA role at a GLP/GMP facility or a minimum of a three years in an analytical/bioanalytical laboratory environment, preferably within a CRO industry, that is under GLP regulation.
• Must be Well acquainted with all GLP requirements (including internal, clients and regulatory audits).
• Immunochemistry, flow cytometry and genomic knowledge and experience are required.

*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. The salary range estimated for this position is $60,600 - $78,600. 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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