Job OverviewProvide scientific support for preclinical and clinical research or laboratory-based studies; perform basic to complex study management tasks and interpretation and reporting of study data/conclusions.
Job Description• Oversee study start-up procedures requiring cross-departmental interaction with all key study personnel.• Assist in generating study protocols and laboratory-based procedures for various regulatory guidelines and obtain sponsor approval.• Assist in assuring that all data for the studies are accurately recorded and verified.• Review, interpret, integrate, and present basic to complex data on assigned studies, with limited assistance from departmental scientific staff.• With minimal guidance from senior scientific staff, function as a study director or project scientist on assigned studies of basic complexity and participate in method development and validation activities.• May serve as an interim or alternate (secondary) scientific contact in the event an assigned study director or project scientist is unavailable.• Ensure project is in compliance with GLP regulations as they apply to the conduct of preclinical and clinical research.• Provide leadership and technical guidance and serve as a mentor to less experienced staff.• Collaborate with scientific and technical staff to develop new techniques and/or models.• Contribute to department operations improvement in areas such as process development, SOP revisions, department inspections, and equipment maintenance.• Shadow the study director or project scientist to further develop research skills and techniques.• Attend scientific meetings, conferences, and training courses to enhance job and professional skills.• Perform all other related duties as assigned.
Education and Experience Requirements- Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Master's degree preferred.
Experience: 4 to 6 years related experience in animal science, biology, chemistry/pharmacy, or similar laboratory environment, including 2 years related experience in the contract research or pharmaceutical industry.
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: Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations.
Workplace Requirements• While performing the duties of this job, the employee is regularly required to talk, hear and work/ type at a computer.• Specific vision abilities required by this job include close vision and the ability to adjust focus.• General office working conditions, the noise level in the work environment is usually quiet.• While performing the duties of this job the employee may occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots), work near toxic or caustic chemicals, work with biohazards, and/or work with live animals with risk of exposure to allergens and/or zoonotic diseases.• The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.
About Safety AssessmentCharles 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 RiverCharles 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.
