Data Coordinator 1

Data Coordinator 1 Req ID #:  105336 Location: 

Ashland, OH, US, 44805 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 Data Coordinator 1forour Safety Assessment Group site locatedin Ashland, OH.

Responsible for production of data tables and figures from various data collection systems with a moderate level of supervision/instruction. Responsibilities include maintenance of the client portal, review of study records, and preparation of all report tables for submission to the client and governmental regulatory agencies.

ESSENTIAL DUTIES AND RESPONSIBLITIES:• Attend 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.

• Assist Study Director and department management in monitoring progress of assigned studies.

• Prepare requested update tables and/or figures for Sponsors.

• Collation and quality control of data and report pieces.

• Preparation, verification, and proofreading of report tables.

• Routine print-editing and post-processing of report tables.

• Running statistical analysis programs.

• Generation of manual report tables, Common Technical Documents (CTD), and any other regulatory agency summary table requirement (as needed).

• Maintaining active record of data table and report transfers during generation and review.

• Collaboration with other appropriate company personnel as needed

• Assist with training of new employees as needed.

• Other duties as assigned by departmental management

QUALIFICAITONS:

• Education: AS degree in a natural sciences/technical writing/computer sciences field.

• Experience: 1-2 years related experience in clerical or administrative related discipline.

• Certification/Licensure: None

• Other: Proficient with Microsoft Office® (e.g., Word, Excel, Outlook), Adobe Acrobat PDF software, and appropriate publishing software. 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 is essential. Completed training in use of Provantis, Nevis, WTDMSTM (including print-editing).Knowledge of GLP regulations.

Job Qualifications

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 14,000 employees within 80 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 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

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 2018.

Equal Employment Opportunity

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

Nearest Major Market: Cleveland

Nearest Secondary Market: Mansfield

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