Support Scientist II
About the role
We are seeking an experienced Support Scientist II for our Study Directors Team in Mattawan, MI. The Support Scientist II provides administrative, logistical, and technical support for scientific staff conducting studies or supporting laboratory operations. This role assists with study management, data handling, quality assurance, and preparation of study-related documents.
Responsibilities
- Provide administrative, logistical, and technical support for scientific staff conducting studies or supporting laboratory operations.
- Coordinate laboratory support, pre-study activities, method development, method validation, study activities, data, and/or reporting activities.
- Review data for completeness, quality, or QC against applicable protocols or procedures.
- Draft client correspondence, study correspondence, reports, or engage in direct client interaction.
- Interact with other departments, scientific staff, and sponsors locally or across sites.
- Initiate preparation of draft study protocols/study plans for standard and complex studies.
- Receive, review, and recommend corrections to draft study protocols/study plans under Study Director (SD) supervision; verify documents against client-specific requirements in the common information database (CID).
- Extract information from final protocols/study plans and study data to prepare study updates for the SD/Sponsor; review, integrate, and/or present basic data on assigned studies with SD guidance.
- Assist in preparation of animal ethical project review summaries.
- Generate amendments to protocol/study plans for all types of studies.
- Review and/or process specialty data; maintain historical databases; 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); prepare CTDs.
- Serve as an interim or alternate (secondary) contact internally if an assigned study director or project scientist is unavailable.
- Assist with identifying training needs.
- Verify that study data are accurately recorded and verified.
- Create/customize planning tools to facilitate prioritization of daily activities.
- Perform other related duties as assigned.
Requirements
- Bachelor’s degree with 2 years of research assistant experience; contract research organization (CRO) experience preferred.
- Client-facing customer service experience preferred.
- Ability to communicate verbally and in writing at all levels inside and outside the organization.
- Basic familiarity with Microsoft Office Suite.
- Computer skills commensurate with essential duties, including the ability to learn validated systems.
- Ability to work extended hours, including evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.
- Ability to work under specific time constraints.
- Must be authorized to work in the United States without a sponsor visa, now or in the future.
Pay
$27.00/hour USD. Salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About the team
Charles River’s Safety Assessment team is committed to helping partners expedite preclinical drug development with exceptional services, state-of-the-art facilities, and expert regulatory guidance. From individual specialty toxicology and IND-enabling studies to tailored packages and total laboratory support, our experienced team designs and executes programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year, approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About the company
Charles River is an early-stage contract research organization (CRO) with a foundation in laboratory animal medicine and science. We offer a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, supporting clients from target identification through preclinical development. Our services also include clinical laboratory testing and manufacturing support. With over 20,000 employees across 110 facilities in over 20 countries, we provide global resources and multidisciplinary perspectives to address client challenges. Our client base includes pharmaceutical companies, biotechnology firms, government agencies, hospitals, and academic institutions worldwide. We are passionate about improving the quality of people’s lives and have contributed to 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.