Member of the clinical team responsible for conducting clinical studies according to Federal Regulations and ICH guidelines for new and modified in vitro diagnostic products. This individual will be assigned to one or more projects and will assist with coordination of study activities including; assisting senior staff in study conduct and case report forms (CRFs), reagent and sample accountability, monitoring clinical documents, analyzing and evaluating clinical data generated during clinical studies, and assists with assembly of regulatory submission documents. Responsible for assisting with basic study protocols, monitoring documents to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, reviewing study specific documents, and study summary records. The individual ensures study compliance with protocol, clinical brochure, and overall clinical objectives. This individual must work independently, communicate and coordinate well with others on study and projects teams. Has established a high degree of competence in clinical research. Has obtained prior exposure to all aspects of a clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research. IVD experience highly preferred, but not required. Travel is required ~25 - 30%.
- Complies with all policies, established procedures, regulations and Good Clinical Practice (GCP).
- Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments.
- Prepares clinical plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.
- Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.