May review and approve trip reports, track data query reports, site visit metrics, and overall site performance May perform routine monitoring at limited clinical sites May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues May assist in the preparation of, and may present at investigator vendor meetings and workshops Actively involved in the performance of study feasibility assessments Provides rapid action to address both internal and site QA findings from audits Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation Routinely participates in department and clinical trial team meetings and participates in collaborative efforts (e.g. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren's Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases.