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Study Coordinator 1, Report Writing

Req ID #:  45629
Location: 

Ashland, OH, US, 44805

For nearly 70 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 e perform. In return, we’ll help you build a career that you can feel passionate about.

 

 

We are seeking an experienced Study Coordinator 1 for our Saftey Assessment Site located in Ashland, OH

Responsible for monitoring of study progress from initiation to completion and generation of end-of-study reports for assigned studies with regular supervision/instruction. Ensure that reports adhere to study protocols, standard templates and styles, Sponsor templates and styles, and applicable regulations. Assist with providing information/data requested by Sponsors. 

 

The following are minimum requirements related to the Study Coordinator 1 position.

  • Attend post-award and/or pre-study meetings and monitor events during the in-life phase to assure a full understanding of assigned projects and results, including objectives, timelines and reporting requirements.
  • Participate in client interactions.
  • Function as lead writer for standard study reports.
  • Ensure that all protocol and amendment requirements are met with respect to final report data.
  • Ensure final reports meet regulatory and client requirements.
  • Review of data tables from multiple data collection systems.
  • Generation of Common Technical Documents (CTD) and any other regulatory agency summary table requirement (as needed).
  • Ability to interpret scientific data and schedule pre-writing meeting with Study Director.
  • Proficient in generating reports in one major area.
  • Provide editorial/formatting review of final study protocols, amendments and report text. Provide comments and/or suggested changes to Study Director.
  • Other duties as assigned by departmental management.

 

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 120 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 11,000 employees within 70 facilities in 18 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. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.

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 ~70% of the drugs approved by the FDA in 2016.

For more information, please visit www.criver.com.


Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet


Nearest Major Market: Cleveland
Nearest Secondary Market: Mansfield

Job Segment: Toxicology, Biotech, Pharmaceutical, Laboratory, Science, Research