Massachusetts Jobs

Study Coordinator, Sample Management

Req ID #: 223393

Location:

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

Coordinate all study related department activities to ensure compliance with the protocol, applicable study documentation, and applicable SOPs. Provide guidance to technical staff on assigned study projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Proficient in preclinical or clinical study set up in LIMS system. Ability to cross train between the two disciplines.

• Read study protocols or Sponsor guidance documents and extract pertinent information related to required action items and provide recommendations to study director/supervisor on technical and logistical aspects of protocol design.

• Perform tasks related to preparation and documentation of materials in support of sample management. Includes entry of relevant information into LIMS systems or current database and assisting with outgoing shipments.

• Assist other sample management staff and study directors with sample discrepancy resolution as needed.

• May work in conjunction with other departments to coordinate assignments to facilitate scheduling of study-related processes on assigned studies to ensure protocol or study requirements are met.

• Assist in the preparation and review of department calendars using protocols and other study documents to ensure all activities are appropriately scheduled.

• Act as liaison between department staff, other departments, and sponsors on assigned studies.

• May communicate with Sponsor representatives (e.g., the Sponsor, or third-party laboratories) on protocol-driven, study related activities.

• Assist sample management staff with study related activities.

• Review and file study data generated/collected by the technical staff.

• Serve as a model as it relates to effective time management, communication and utilization of resources, and safety in the laboratory. Perform a wide variety of laboratory tasks independently.

• Maintain and perform record keeping.

• Perform all tasks in compliance with Good Laboratory Practice Regulations (GLPs), Good Clinical Practice Regulations (GCP), and Standard Operating Procedures (SOPs).

• Perform all other related duties as assigned.

The pay range for this position is between $30.00 and $36.00 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: High school diploma or General Education Degree (G.E.D.) required. Associate's (A.A/AS.) degree in a life sciences field preferred.

• Experience: Minimum of 3-5 years related experience, including GLP and/or GCP experience required, or must have demonstrated full knowledge of competencies and positive performance at the previous level.

• 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: Good keyboarding skills, proficient in utilizing personal computer, e-mail and standard office software packages (word processing, spreadsheet, presentation, database). Ability to work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Acts independently to determine processes and procedures on new assignments and may provide guidance and oversee the activities of other support personnel.

PHYSICAL DEMANDS:

• 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:

• General office working conditions, the noise level in the work environment is low.

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 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.

For more information, please visit www.criver.com.