Support Scientist II

Job Overview

We are seeking an experienced Support Scientist II for our Study Directors Team in Mattawan MI
.

A Support Scientist II is responsible for: providing administrative support to study directors (SD) for management of data and preparation of protocol/study plans and study reports. The individual in this role assists with providing requested data/information; performs basic study management tasks and may assist with management of study data and quality assurance (QA) audits, including follow‑up actions.

The pay for this position is $27.00/hr USD
. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Provides administrative, logistical and technical support for Scientific staff conducting studies or supporting functions for operations of the laboratory. Coordinates all laboratory support, pre‑study activities, method development, method validation, study activities, data and/or reporting activities. Responsible for data review for completeness, quality or QC against the applicable protocol or procedure. May be responsible for drafting client correspondence, study correspondence, reporting or direct client interaction.

Interacts with other departments, scientific staff, and sponsors either locally or across sites.

• Initiate preparation of draft study protocols/study plans for standard and more complex studies.
• Receive, review and make recommended corrections to draft study protocols/study plans, under SD supervision; verify documents against client‑specific requirements indicated in common information database (CID).
• Extract information from final protocol/study plan and study data to prepare study updates for the SD/Sponsor; may review, integrate, and/or present basic data on assigned studies with guidance from SD.
• Assist in preparation of animal ethical project review summary.
• Assist in generating amendments to protocol/study plan for all type of studies.
• May review and/or process specialty data; may maintain historical databases current; 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.
• May serve as an interim or alternate (secondary) contact internally in the event 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.
• Performs other related duties as assigned.

• Education and Experience:
  
  Bachelor’s degree with 2 years of research assistant experience; contract research organization experience preferred.
• Client‑facing customer service expereince preferred.
• Certification/Licensure:
  None.
• 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 and Responsibilities, including the ability to learn a validated system.
• Ability to work extended hours beyond normal work schedule to include, but not limited to 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.

Charles River is committed to helping our partners expedite their pre‑clinical drug development with exceptional safety assessment 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 deeply experienced team can design and execute 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.

Charles River is an early‑stage contract research…