Scientific Coordinator
Job Summary
We are seeking a Scientific Coordinator for our Safety Assessment (SA) site located in Stilwell, Kansas (KAN). This role supports a key shift in the way non-GLP integrated toxicology studies are managed in SA, aligning with the vision of the integrated toxicology (ITox) business model. This role will be responsible for the oversight and coordination of studies. This role is also responsible for assisting in the compilation of study data/reports and providing study related information to Sponsors.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Engage in the creation/customization of planning tools to facilitate prioritization of study deliverables.
- Interact regularly with sponsors: send amendments and documents for signature, respond to sponsor-requests for information and tables, and assist with sponsor on-site visits. Serve as primary point of contact to the sponsor.
- Preferred experience with lead optimization study design, execution and/or Discovery operations.
- Serve as a model as it relates to effective time management, communication, and utilization of resources. Provide leadership and motivation to departmental personnel.
- Ensure that schedule for study deliverables is met and any impacts to timelines are addressed promptly.
- Monitor studies within the Vivarium and provide summarized details about animal health and study details as needed to Laboratory animal medicine and/or Sponsor.
- Excellent communication and interpersonal skills.
- Strong leadership qualities including an “agile” mindset; understanding, collaborating, learning, and staying flexible to achieve high-performing results.
- Demonstrated ability to multitask and problem solve in a fast-paced environment.
- Familiar/comfortable at a higher volume/pace environment.
- Write initial protocol drafts, distribute draft protocols for internal and/or sponsor review, and coordinate amendment/revision process.
- Facilitate signature/approval process for protocols, amendments, and other required forms.
- Generate/format data for reporting.
- Maintain study in-life and reporting timelines (deliverables).
- Ensure that all study information is recorded accurately, organized, and QC’d.
- Assist in preparation of animal ethical project reviews, including IACUC form preparation and IACUC literature searches.
- Assist in recording and remediation of study errors.
- May conduct sponsor/visitor tours and interact with clients.
- Initiate preparation and/or approval of study protocols/study plans, amendments, and other required forms for standard and more complex studies.
- Receive, review, and make recommended corrections to study protocols/study plans; verify documents against client-specific requirements indicated in common information database (CID), if applicable.
- Extract information from final protocol/study plan and study data to prepare study updates for the Sponsor; integrate, and/or present basic data on assigned studies to Sponsors.
- Assist in generating amendments to protocol/study plan for all type of studies.
- May review and/or process specialty data; may maintain current historical databases; may prepare materials/methods sections of reports.
- Perform quality control (QC) of draft reports (toxicology main reports and/or PI/IS sub-reports) and common technical documents (CTD); may prepare CTDs.
- Assist with identifying training needs.
- Create/customize planning tools to facilitate prioritization of daily activities.
- Perform all other related duties as assigned, including on study in-life procedures.
Job Qualifications
- Education: Bachelor’s degree (B.A./B.S.) or equivalent in scientific related discipline preferred.
- Experience: 1-2 years experience as a Study Coordinator / Study Supervisor or 3-5 years as a Lead Tech /Vet (or similar role).
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: AALAS certification ALAT/LAT level strongly preferred; or other applicable certification/licensure.
- Other: Demonstrated advanced technical and analytical skills. Effective communication and leadership skills. Ability to handle a variety of laboratory animals. Proficient in technical skills and the operation of data collection equipment. Knowledge of federal regulations and guidelines relating to the care of laboratory animals required. Understanding of basic, intermediate, and complex study design and protocols. Ability to organize and prioritize work to meet deadlines. Computer literacy including word processing, spreadsheet, and database programs.