Clinical Support Services Coordinator I
Shrewsbury, MA, US, 01545
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 Summary
Support all aspects of Clinical Support Services to ensure compliance with protocols, study documentation and applicable SOPS. Communicate with clients, client representatives and multiple groups to assure the smooth flow of studies through the study process.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
⦁ Prepare, review and ship clinical kits and supplies for clients in compliance with relevant Standard Operating Procedures (SOPs) under the guidance of senior personnel
⦁ Assist in the customization and design of site manuals, clinical kits and materials for clinical studies
⦁ Receive and accession clinical and non-clinical regulated study samples following Good Laboratory Practices (GLPs) and SOPs
⦁ Work with clients and/or sample management group and/or senior scientific staff to address/resolve clinical and non-clinical regulated study sample and manifest discrepancies in compliance with Good Laboratory Practices (GLPs), SOPs, study protocols or Sponsor guidance documents and company policies/practices.
⦁ Create, modify and maintain clinical and non-clinical regulated studies within a LIMS system under the guidance of senior staff.
⦁ Read study protocols or Sponsor guidance documents and extract pertinent information related to study creation and reporting requirements.
⦁ Coordinate flow of study information between clients and bioanalytical teams
⦁ Follow company SOPs and guidelines
⦁ Ensure that raw data records are accurate, complete, and in appropriate order
⦁ Provide cross-functional support to other service lines as needed
⦁ Perform all other related duties as assigned.
The pay range for this position is between $23 and $26 an hour . Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
Job Qualifications
QUALIFICATIONS:
⦁ Education: Associates degree required, Bachelors (B.A./B.S.) degree preferred.
⦁ Experience: 0-2 years related laboratory experience, preferably in a pharmaceutical or contract laboratory 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.
⦁ Other: Must be detail-oriented and have general familiarity with lab procedures. Knowledge of FDA GLPs. Good verbal communication skills required. Ability to organize and prioritize work to meet deadlines under minimal direction. Basic computer skills; familiarity with Microsoft Office software and Watson LIMS. Knowledge for regulations for shipment and receipt of samples / kits domestically and internationally.
PHYSICAL DEMANDS:
⦁ Employees must be able to lift, move, manipulate, and/or hold heavy objects up to and including 40 pounds; this includes work materials, equipment, and/or supplies.
⦁ Must be able to perform procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
⦁ Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.
⦁ Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
WORK ENVIRONMENT:
⦁ Works in a research environment, which requires use of sharp objects, working around mechanical parts, working with or near known or unknown toxic or caustic chemicals and/or biological hazards, exposure to fumes and airborne particles, working at noise levels ranging from moderate to loud.
⦁ The employee is occasionally exposed to live animals with risk of exposure to allergens, zoonotic disease, and biohazards.
⦁ The noise level in the work environment ranges from low to moderate depending upon the task being performed.
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 (including sexual orientation, gender identity, and expression), 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 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: Worcester
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