Report Coordinator 1 (Temporary)

Report Coordinator 1 (Temporary) Req ID #:  107552 Location: 

Cleveland, OH, US, 44128 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 Temporary Report Coordinator 1 for our Safety Assessment group site located in Cleveland, Ohio.

Under the supervision of the Senior Director, Operations, the Technical Writer is responsible for general documentation compliance. The Technical Writer works under applicable regulatory conditions, including but not limited to FDA Regulations: 21 CFR Part 58 (Good Laboratory Practices}, 21 CFR Part 210 and 21 CFR Part 211 (current Good Manufacturing Practices)"

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Drafting technical reports in the company format in accordance with the study protocol, FDA Good Laboratory Practice Regulations, and ChanTest Standard Operation Procedures;

• Developing and maintaining protocol and report templates;

• Maintaining the company Standard Operating Procedures (SOP) files and controlled forms;

• Performing QC checks of study reports;

• Reviewing and proofing study reports for accuracy;

• Making sure all GLP studies are in proper order and all needed documentation is in the study file before QAU inspection;

• Working with the Study Directors to ensure that all raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study;

• Performs non-GLP review of safety testing study reports, as directed by the supervising manager;

• Works on other projects as assigned by the supervising manager.

Job Qualifications

• Education: H.S. diploma required.

• Experience: Computer skills including word processing

• Certification/Licensure: None.

• Other: Key skills include attention to detail, personal computer literacy, a good understanding of scientific procedures and excellent interpersonal and organizational skills. Ability to interact effectively with diverse personalities and ethnic backgrounds isessential.

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 17,000 employees within 90 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. And in 2019, revenue increased to $2.62 billion.

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 ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

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

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.

Nearest Major Market: Cleveland

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