Nutramax desires to provide a drug-free, healthful, and safe workplace. We hold a zero-tolerance policy for drug use. Employment is contingent upon successfully passing a preemployment background check and drug screen (subject to applicable law).
This position is 100% on site in our Lancaster, SC Headquarters (roughly 45 min - 1 hour south of Charlotte, NC).
Summary of the Position: The Clinical Research Associate is responsible for assisting in clinical trials from initiation to completion through participating in the development of study protocols, case report forms and clinical reports, as well as performing site monitoring visits and interfacing with site staff, Clinical Research Organizations (CRO), and other company representatives. This position is also responsible for supporting clinical trials as required.
Roles and Responsibilities:
· Facilitate the development of study protocols, reports, SOPs, NDAs and research agreements by coordinating input from various sources including literature, experts, and internal team members.
· Coordinates and conducts study protocol training at study sites and appropriate documentation.
· Select and manage investigational sites and clinical trial vendors such as CROs and external laboratories.
· Facilitate the development of study documentation including case report forms, informed consent forms, source documentation and study-specific plans for sound and thorough data to support the approval process or study objective.
· Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
· Assure procedures are in adherence with the assigned study protocol and in accordance with good clinical research principals.
· Monitors clinical studies and provides reports throughout study execution.
· Perform quality checks on data, analytical results, study procedures and materials.
· Obtain and coordinate results of information from blood samples and laboratory analysis as described in study protocol.
· Prepare data for statistical analysis.
· Assist in preparation of final study reports, scientific abstracts and manuscripts for publication.
· Represent company at veterinary conferences and trade shows.
· Communicate effectively with other departments within the organization and function within a team environment.
· Review journals, abstracts and scientific literature to keep abreast of new developments.
· Perform other Clinical Operations duties, as requested
Minimum Requirements: Basic knowledge of scientific principles and practices. Excellent writing, interpersonal, communication, and organization skills required. Must be detail oriented and work collaboratively with internal and external teams. Must be proficient in computer usage, such as word processing, spreadsheets, and/or databases. Knowledge of MS Access desired. Experience with Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs) regulations, and Standard Operating Procedures (SOPs), a PLUS. Some travel required for monitoring clinical studies, attending conferences and trade shows (20% travel required).
Education and Experience: Master’s degree or bachelor’s degree with equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences. Certifications such as CVT, LVT, RVT, or CVPM.
Supervisory Responsibilities : None
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