Study Coordinator 3

Study Coordinator 3 Req ID #:  98333 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 Study Coordinator 3 for our Safety Assessment group site located in Cleveland, Ohio.

Perform the collection, preparation and distribution of information necessary for protocol development and study initiation for all levels of studies. Assist the Study Director during in- and post-life by providing and coordinating scientific and administrative support and in the production of a high quality, accurate and timely study report. Assist in mentoring and training other Study Coordinators.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Prepare study-specific protocols consistent with the requirements of the Sponsor, laboratory SOPs and applicable government and regulatory body guidelines and GLPs.

• Prepare schedules for study-specific protocols; review schedules for consistency with laboratory scheduling system and update the schedule as required.

• Distribute draft protocols for internal/Sponsor review, coordinate protocol finalization process, and distribute and track distribution of final protocols and completed approval pages to the Sponsor, facility staff and subcontractors.

• Coordinate costing of study-specific protocols and protocol revisions with Client Services, ensure communication of study prices to the Sponsor with corresponding protocol drafts for approval, and ensure inclusion of necessary contract information with the final protocol when sent to the Sponsor.

• Coordinate revision of draft protocols in response to Sponsor requests, QAU audits and internal review, and prepare response letters to Sponsors documenting draft protocol revisions.

• Prepare and/or verify test article/substance and required analysis information with Formulations Department for inclusion in the protocol.

• Generate study timelines for study reports.

• Assist in notifying departments of new information or design changes for upcoming studies in a timely manner.

• Provide internal QC via peer review of protocols.

• Track availability and scheduled receipt of test article/substance shipments to ensure study start.

• Assist in any additional pre-study preparations as necessary (e.g., drafting new Standard Operating Procedures).

Job Qualifications

• Education: Bachelor's degree (BS/BA) or equivalent, preferably in a life science.

• Experience: Three to 4 years' experience in a GLP laboratory environment.

An equivalent combination of education and experience may be accepted as a satisfactory

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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