The Clinical Research Associate will lead clinical studies and/or parts of studies. The associate will be responsible for leading clinical study activities and procedures. Duties also include execution of experimental protocols and specimen processing.
Essential Duties and Responsibilities
• Lead clinical research activities and study management.
• Liaison with Clinical Services, Medical Director, Veterinary Director, and Clinical Consultants to lead special test requests and results delivery.
• Responsible for process of sample de-identification, coding, blinding and randomization for FDA and IRB compliance in clinical research
• Lead human and/or veterinary clinical trials and other studies, as applicable, with collaborating institutions and prepare associated documentation.
• Specimen processing, storing, shipping and sample set preparation/documentation
• Perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.)
• Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools).
• Lead budget and contract negotiations with clinical trial sites.
• When applicable, training of additional personnel on clinical trial activities.
• Ensure work is aligned with all relevant quality requirements.
• Participates in and adheres to the Quality Program
• Adhere to safety SOPs and report potential safety hazards.
• Must be able to work productively and independently in an interdisciplinary team environment.
• Other duties as assigned
Education
• B.A. or B.S. in Biology, Microbiology, Biochemistry or other Scientific Field or pertinent experience preferred.
• Minimum of 4 years pertinent industry experience preferred.
• SOCRA CCRP preferred.
Skills, Specialized Knowledge and Abilities
• Must be able to work productively and independently in an interdisciplinary team environment.
• In-depth knowledge of research principles and Good Clinical Practice (GCP).
• The candidate should have experience with protocol development and the ability to grasp in-depth scientific study design and regulatory principles related to the products being evaluated in the course of the clinical research.
• In-depth knowledge in the areas of microbiology, immunology or molecular biology and biochemistry preferred.
• Strong skills in database management.
• Strong attention to detail and problem solving abilities.
• Must possess exceptional communication (written and verbal), interpersonal and problem solving skills.
• Computer proficiency (Microsoft products)
• Highly motivated, readily adapts to changing priorities, effectively manages own time to ensure tasks, multiple projects are completed on time.
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