Job Description

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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