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Scientific Coordinator

For 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 we perform. In return, we'll help you build a career that you can feel passionate about.




Job Summary


We are seeking a Scientific Coordinator for our Safety Assessment Group site located in Ashland, Ohio.


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.


Provide protocol and report support to study directors, and assist with providing information/data requested by sponsors. Assist with management of QA audits and assure necessary corrections and follow-up take place.


ESSENTIAL DUTIES AND RESPONSIBILITIES:  



  • 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.

  • Create/customize planning tools to facilitate prioritization of daily activities.

  • Interact regularly with sponsors: send amendments and regulatory forms for signature, respond to sponsor-requests for information and tables, and assist with sponsor on-site visits.  Serve as primary point of contact to the sponsor when study director is not available.

  • With guidance, write initial protocol drafts. Upon study director approval, distribute draft protocols for internal and/or sponsor review, and coordinate amendment/revision process.

  • Facilitate signature/approval process for protocol, amendments and other required forms.

  • Tabulate study data and schedule data review meetings.  

  • Create/generate special tables for sponsors as needed.

  • Assemble report (text and data tables) for senior scientific review, QA audits, and final report compilation. 

  • Assist with management of QA audits and assure necessary corrections and follow-up take place.

  • Ensure that all study books are corrected appropriately, and that documentation is GLP compliant prior to submission to QA.

  • Assist in IACUC form preparation and perform IACUC literature searches.

  • Assist in documentation of deviations from the protocol or Standard Operating Procedures (SOP).  Assist in drafting new or study specific SOPs.

  • Perform all other related duties as assigned.

     


    QUALIFICATIONS:


  • Education:  Bachelor's degree (B.A./B.S.) or equivalent in science or related discipline.

  • Experience:  2-4 year related experience in a laboratory or scientific research environment.

  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

  • Certification/Licensure:  None.


Other:  This position requires analytical thinking skills and a good understanding of scientific processes. Strong organizational skills and attention to detail required, as are computer skills including MS Office software and database management. Must be familiar with medical



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 13,000 employees within 80 facilities in 23 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 80% of the drugs approved by the FDA in 2017.


 


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


 


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




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