Study Coordinator I

Req ID #: 233465

Ashland, OH, US

1st

Full time

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, we’ll help you build a career that you can feel passionate about.

Job Overview

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/PI and assist with providing information/data requested by Sponsors

The Salary range for this position is $49,000 – $57,000 annually. Please note that starting salaries vary based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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/PI 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/PI.
• Proficient in generating reports in one major area.
• Other duties as assigned by departmental management.

QUALIFICATIONS:

• 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/Licensure: None.
• Must be authorized to work in the United States without a sponsor visa, now or in the future.
• 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 Ibs.
• 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.

Education

Four-year degree required

Physical Requirements

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 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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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