SCIENTIST I – Study Coordinator
Job Description
The Study Coordinator is responsible for supporting the planning, coordination, execution, and documentation of non-clinical studies within the limits defined by their training and experience. This position works closely with Study Directors, Scientists, technical staff, and other study personnel to help ensure studies are conducted efficiently, accurately, and in accordance with applicable protocols, standard operating procedures (SOPs), regulatory requirements, and client expectations.
The Study Coordinator assists with day-to-day study activities, monitors study progress, coordinates study resources and personnel, maintains accurate study documentation, and helps identify and resolve issues that may affect study timelines or quality.
Key Job Responsibilities:
- Coordinate and support the day-to-day activities associated with assigned non-clinical studies.
- Assist with study planning, scheduling, and coordination of study activities and personnel.
- Coordinate study resources, equipment, test systems, and other materials as needed to support study execution.
- Monitor study schedules and progress and communicate potential delays, scheduling conflicts, or other issues to the appropriate Study Director or management.
- Conduct or assist with study procedures and technical activities within the limits of the employee's training and qualifications.
- Assist with test system handling, restraint, test substance administration, sample collection, observations, and other study-related procedures as assigned.
- Ensure study activities and experimental data, including observations and unanticipated responses of the test system, are accurately recorded, documented, and verified.
- Maintain complete and accurate study records, files, and supporting documentation in accordance with applicable SOPs and study requirements.
- Assist with preparation, review, and maintenance of study documentation, including amendments, deviations, reports, regulatory submission materials, and responses, as applicable.
- Perform or assist with quality checks of study data and documentation to support data accuracy and completeness.
- Communicate study status, activities, and issues to Study Directors, Scientists, and other appropriate personnel.
- Coordinate the efforts of assigned study personnel and provide direction related to study activities, as appropriate.
- Assist with training and onboarding of junior staff on study procedures, protocols, SOPs, and applicable work practices.
- Assist with identifying opportunities to improve study processes, efficiency, documentation, and overall team performance.
- Support the completion of studies according to protocols, timelines, SOPs, applicable regulatory requirements, and client expectations.
- Assist in resolving routine study-related issues and elevate significant or unresolved issues to the appropriate Study Director or management.
- Support and administer company policies and procedures.
- Maintain professional and effective communication with internal departments and, as appropriate, clients and other external contacts.
- Perform other duties and responsibilities as assigned.
Supervision:
The Study Coordinator reports to the Scientist or Associate Director, or other designated member of management.
This position may provide day-to-day coordination, guidance, and training to junior study personnel but does not necessarily have formal supervisory responsibilities.
Required Skills/Abilities: