Study Coordinator I, Sample Processing

About the Role

Entry level scientist developing skills to understand sample processing and Watson study designs. This role involves foundational knowledge of data collection systems, protocol development, regulatory compliance, and internal systems utilized in the conduct of a study. The Study Coordinator I will independently adhere to TK/SPL timelines in preparation of Watson manifests, samples, and other study movements.

Responsibilities

• Attend post-award and/or pre-study meetings and monitor events during the in-life phase to assure a full understanding of assigned projects and results.
• Create/customize planning tools to facilitate prioritization of daily activities.
• Interact regularly with study directors: send short sample communication, labeling or manifest discrepancy, changes in planned TK collections.
• Prepare all Watson aspects from study design and label preparation through shipping, archival, or disposal.
• Assist with management of QA audits and assure necessary corrections and follow-up take place.
• Assist in documentation of deviations from the protocol or Standard Operating Procedures (SOP).
• Perform all other related duties as assigned.

Qualifications

• Education: High School degree 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 (B.A./B.S.) or equivalent in science or related discipline, strongly recommended.
• Experience: 2–4 years of related experience in a laboratory or scientific research environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute.
• Skills: Analytical thinking and a good understanding of scientific processes. Strong organizational skills, attention to detail, and proficiency in computer skills including MS Office software and database management. Familiarity with medical terminology and a thorough understanding of technical aspects of research studies (e.g., observing dosing, treatments, surgical procedures, and necropsy evaluations).
• Proficient in technical aspects of the Formulations department (e.g., preparing formulations and use of Provantis Dispense™). Knowledge of GLP regulations and understanding of routine study design and protocols.
• Must be authorized to work in the United States without a sponsor visa now or in the future.

Physical Demands

• Regularly required to talk, hear, work/type at a computer, and reach with hands and arms.
• Specific vision abilities required include close vision and the ability to adjust focus.
• Occasionally wears protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots).
• Works near sharp objects, toxic or caustic chemicals, and biohazards.
• Occasionally works near live animals with risk of exposure to allergens and/or zoonotic disease(s).
• Exposed to fumes or airborne particles, unpleasant odors, and wet, humid, and/or extreme temperature conditions.

Work Environment

General office working conditions; the noise level in the work environment is usually quiet.

Pay

The pay for this salaried position is $60,000. Salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Charles River

Charles River is an early-stage contract research organization (CRO) with over 75 years of experience assisting in the discovery, development, and safe manufacture of new drug therapies. 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. Our services also include products and support for clinical laboratory testing needs and manufacturing activities.

With over 20,000 employees within 110 facilities in over 20 countries, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives to resolve our clients' unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, hospitals, and academic institutions around the world.

Charles River is committed to helping partners expedite preclinical drug development with exceptional safety assessment services, state-of-the-art facilities, and expert regulatory guidance. Each year, approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.