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Associate Study Director Jobs in Michigan (NOW HIRING)

Director of Research Operations Schedule: Full-time, with flexibility for study visits, sponsor meetings, and operational needs Position Summary The Associate Director of Research Operations is ...

A Study Manager I is responsible to ensure that quality research is conducted at assigned ... Working closely with the Associate Site Director/Site Director to achieve strategic goals for the ...

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GSRP Director Position Type: Stipend Position Position Overview The GSRP Director is responsible ... An associate degree or higher in any field of study * Three hours of MiRegistry-approved training ...

Reese Elementary School GSRP Director Position Type: Stipend Position Position Overview The GSRP ... An associate degree or higher in any field of study * Three hours of MiRegistry-approved training ...

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Associate Study Director information

What is an associate study director?

Associate Study Directors are professionals who assist in the planning, coordination, and management of scientific studies, often within research or laboratory settings. They work under the guidance of a Study Director to ensure studies are conducted according to protocols, regulatory requirements, and quality standards. Their responsibilities may include overseeing data collection, ensuring compliance with Good Laboratory Practices (GLP), managing study documentation, and communicating with clients or sponsors. This role is essential in maintaining the integrity and accuracy of research projects, particularly in fields such as pharmaceuticals, environmental science, and toxicology.

What are some common challenges faced by an associate study director, and how can they be addressed?

Associate Study Directors often face challenges such as managing multiple studies simultaneously, ensuring regulatory compliance, and coordinating communication between cross-functional teams. Balancing strict timelines with high-quality data collection requires strong organizational skills and attention to detail. To address these challenges, it's essential to develop robust project management habits, maintain clear documentation, and foster open communication with both internal teams and external stakeholders. Regular training on regulatory requirements and effective use of study management tools can also greatly enhance efficiency and accuracy in the role.

What are the key skills and qualifications needed to thrive as an associate study director, and why are they important?

To thrive as an Associate Study Director, you need a solid background in life sciences, data analysis, and project management, typically supported by a relevant degree such as biology or pharmacology. Familiarity with laboratory information management systems (LIMS), regulatory guidelines (GLP/GCP), and data reporting tools is crucial. Strong organizational skills, attention to detail, and effective communication are standout soft skills for this role. These competencies ensure studies are conducted accurately, regulatory requirements are met, and projects are delivered on time.

What is the difference between Associate Study Director vs Study Director?

AspectAssociate Study DirectorStudy Director
CredentialsTypically requires a bachelor's or master's degree in a related field, with some experience in study managementRequires a higher level of education (often a master's or PhD) and extensive experience in study oversight
Work EnvironmentSupports study planning and execution under supervision, often in laboratory or research settingsLeads and oversees entire studies, ensuring compliance and data integrity
Employer & Industry UsageCommonly employed in contract research organizations (CROs) and laboratoriesUsed in similar settings but with greater responsibility and authority

The main difference between an Associate Study Director and a Study Director lies in their level of responsibility and experience. Associate Study Directors support study activities and assist in management tasks, while Study Directors lead and oversee the entire study process, ensuring compliance and quality. Both roles are essential in research and testing environments, with the Study Director holding a more senior position.

What cities in Michigan are hiring for Associate Study Director jobs?

Cities in Michigan with the most Associate Study Director job openings:

Study Director I - General Toxicology

Charles River Laboratories, Inc.

Mattawan, MI

$85K - $88K/yr

Full-time

Medical, Retirement, PTO

Posted 2 days ago

New


Charles River Laboratories rating

8.4

Company rating: 8.4 out of 10

Based on 94 frontline employees who took The Breakroom Quiz

24th of 86 rated pharmaceutical


Job description

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 Research Scientist I for our General Toxicology Study Director Team in Mattawan MI.

A Research Scientist I - Safety Assessment serving as a study director (SD) is responsible for overseeing study conduct of preclinical efficacy and/or toxicology studies assigned by test facility management (TFM) within safety assessment; overseeing protocols/study plans; coordinating with technical teams for execution of studies, including establishing study schedules, verifying that standard operating procedures (SOPs) are available and adhered to, overseeing data recording and reporting, and verifying that regulatory requirements/expectations are met. The individual in this role interprets preclinical toxicity studies, evaluates and prepares reports from the data collected during these studies, communicates with sponsor representatives, and initiates contact with potential clients. May be involved with development of new technologies/procedures.

The pay range for this position is $85,000 to $88,000/yr 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
  • Function as an independent SD, working on studies/programs of basic to moderate complexity. See detailed role and responsibilities of Study Director below:
  • Design, write, review and edit study plans/protocols, amendments and study schedules that define and schedule all study activities.
  • Oversee and coordinate study procedures.
  • Verify that projects are performed according to SOPs and good laboratory practices (GLP) regulations.
  • Write, review and edit draft or final reports that document all study related procedures and results.
  • Communicate with sponsors on study related business.
  • Oversee and coordinate study conduct (protocol development, technical guidance, and reporting).
  • Assist in study planning, scheduling, and execution under the supervision of Sr. Scientist(s)/Scientific Manager.
  • Host client visits and telephone/video conferences.
  • Assists with mentoring less experienced staff and may assist with training of scientific/senior scientific associates as needed.
  • Provides advice to clients and technical teams.
  • May assist with proposal development.
  • Develop an area of expertise.
  • Other duties as assigned.
Minimum Requirements
  • Bachelor’s degree or equivalent in Toxicology or a related discipline; Master’s/PhD/PharmD/DVM/MD degree or equivalent preferred; with 2 or more years of related industry experience.
  • Data interpretation of in-vivo toxicology studies preferred.
  • Overseen or conducted in-vivo toxicology studies preferred.
  • Experience in understanding and implementation of US FDA guidance documents in relation to preclinical testing preferred.
  • Success in this role requires familiarity with: study/project costs and impact of changes, local regulations and GLPs as they relate to primary area of focus, study process from proposal to report, quality assurance (QA)/quality control (QC) processes, IACUC process, the SD role in animal welfare, effective communication with veterinary staff and internal/external clients in a manner that generates confidence and builds trust, and communication with technical supervisor and Scientific Manager on issues of staffing and equipment.
  • Strong communications skills, verbally and in writing at all levels inside and outside the organization.
  • Basic familiarity with Microsoft Office Suite.
  • Computer skills, commensurate with Essential Functions, 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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About Charles River

Sourced by ZipRecruiter

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 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 supported the development of 86% of the drugs approved by the FDA in 2021.

Industry

Scientific research and development services

Company size

10,000+ Employees

Headquarters location

Wilmington, MA, US

Year founded

1947