Study Coordinator - Non-Clinical CRO

Job Description

Job Description

SCIENTIST I – Study Coordinator Non-Clinical CRO

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 escalate 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:

• Working knowledge of non-clinical research and study conduct principles.
• Ability to understand and follow study protocols, SOPs, work instructions, and other technical requirements.
• Strong organizational skills with the ability to coordinate multiple activities and priorities.
• Strong attention to detail and commitment to accurate documentation.
• Ability to identify and communicate study issues, scheduling conflicts, and potential delays.
• Ability to work effectively both independently and as part of a multidisciplinary study team.
• Effective written and verbal communication skills.
• Ability to work within established training and qualification requirements.
• Ability to maintain accurate and complete study records.
• Ability to work effectively in a laboratory and research environment, including handling test systems and performing study procedures as required.

Education and Experience:

• Bachelor's degree in Biology, Chemistry, Animal Science, Toxicology, Pharmacology, or a related scientific field preferred.
• 3–4 years of relevant experience in a laboratory, research, non-clinical, or related scientific environment preferred.
• Equivalent combination of education, training, and relevant work experience may be considered.
• Experience with study coordination, laboratory procedures, study documentation, or working within a regulated research environment is preferred.

Physical Demands:

• This position regularly requires the employee to communicate verbally, listen attentively, and perform computer-based tasks, including typing.
• The role demands specific visual abilities, such as close-up vision and the capacity to adjust focus.
• Extended periods of walking or standing may be necessary.
• Frequent use of fine motor skills is required for handling small laboratory equipment and test subjects with both hands.
• Employees working with test subjects must be capable of lifting, moving, and restraining up to 40 pounds, including both equipment and test subjects of various sizes.
• The position involves frequent bending and stooping

Work Environment:

• While performing the duties of this job, the employee occasionally wears protective clothing (googles, face shield, surgical mask, cap, gloves, scrubs, boots).
• Occasionally works with biohazards and sharps.
• Occasionally works with live test subjects (small, medium and/or large) with risk of exposure to allergens
• While performing the duties of this job the employee is occasionally exposed to fumes or airborne particles, unpleasant odors, and wet, humid and/or extreme temperature conditions
• The noise level in the work environment is usually low and occasionally moderate