Study Director Jobs in Michigan (NOW HIRING)

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
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.
Job Description
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.

Minimum Requirements

• 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.

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical 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.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
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