Study Coordinator I - Ashland, United States - Charles River Laboratories
Description
Study Coordinator I
Req ID #:
Location:
Ashland, OH, US, 44805
For 75 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, well help you build a career that you can feel passionate about.
**Job Summary**
We are seeking an experienced Study Coordinator I to work remotely for our Safety Assessment site located in Ashland, OH.
**BASIC SUMMARY:**
Responsible for monitoring study progress (as applicable) and generation of end-of-study reports for assigned studies with a high level of supervision/instruction. Ensure that reports adhere to study protocols, standard templates and styles, Sponsor templates and styles, and applicable regulations. Provide protocol and report support to SD/Pl and assist with providing information/data requested by Sponsors.
**ESSENTIAL DUTIES AND RESPONSIBILITIES:** _(The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:_
+ Function as lead writer for standard study reports.
+ Attend study meetings as applicable to assure a full understanding of assigned projects and results, including objectives, timelines, and reporting requirements.
+ Participate in client interactions (if applicable).
+ Ensure that all protocol and amendment requirements are met.
+ Ensure reports meet regulatory and client requirements.
+ Generate, format, and/or review report components/text using pre-defined templates.
+ Generate, format, and/or review 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 compile and/or interpret scientific data, meeting with Study Director/Pl as needed.
+ Provide editorial/formatting review of final study protocols, amendments, and report text (as applicable). Provide comments and/or suggested changes to Study Director/Pl.
+ Proficient in generating reports in one major area.
+ Other duties as assigned by departmental management.
**The pay range for this position is 46-57K. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location**
**Job Qualifications**
(Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
+ Education: High School diploma or General Education Degree (G.E.D.), preferred. Associate's degree (A.A./A.S.) or equivalent from a two-year college, recommended. Bachelor's degree (BA/BS) or equivalent in science or related discipline, strongly recommended.
+ Experience: 1-2 years 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/Llcensure: None.
+ Other: This position requires analytical thinking skills and a good understanding of scientific processes. Strong interpersonal/organizational skills and attention to detail are required, as well as strong written, verbal, and analytical skills. Must be proficient with spreadsheet, word processing, and publishing software. Familiarity with preclinical study protocols/reports, knowledge of GLP regulations/FDA electronic reporting compliance, and scientific/medical writing and terminology preferred. Ability to adjust priorities to adhere to stringent deadlines. Ability to work with all levels of staff. Ability to interact effectively with diverse personalities and ethnic backgrounds is essential.
**PHYSICAL DEMANDS:**
+ While performing the duties of this job, the employee is regularly required to talk, hear, and type at a computer.
+ Able to lift up to 50 lbs.
+ Specific vision abilities required by this job include close vision and the ability to adjust focus.
+ Must be able to regularly sit approximately 6 to 8 hours a day.
+ Must be able to frequently type an average of 6 hours a day.
+ Must perform data entry to and make edits on information contained on a personal computer.
+ Must be able to regularly communicate with personnel inside/outside the company as appropriate
**WORK ENVIRONMENT:**
+ General office working conditions, the noise level in the work environment is usually quiet.
**COMMENTS:**
+ This position may require overtime, weekend, and/or after hours shift coverage, as needed.
**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 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients 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 peoples 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 86% of the drugs approved by the FDA in 2021.
**Equal Employment Opportunity**
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
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 [email protected] . This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
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