Teams at Alira Health

Conducts remote and onsite clinical trial monitoring visits, including site qualification, initiation, interim, and close-out activities. Ensures protocol, ICH GCP, regulatory, and SOP compliance; verifies source data, manages investigational product accountability, reviews regulatory documentation, and supports adverse event reconciliation. The role addresses site issues, recruitment, training, audits, budgets, CTMS activities, and sponsor communication while mentoring CRAs and coordinating with cross-functional clinical teams.

Conducts remote and onsite clinical trial monitoring visits, ensuring protocol, ICH GCP, FDA, regulatory, and sponsor SOP compliance. Reviews source documents, CRF data, regulatory binders, and trial files; manages investigational product accountability, adverse event reconciliation, site issues, recruitment, and audit preparation. Supports monitoring plans, budgets, training, CTMS activities, sponsor communication, and CRA mentoring while coordinating with cross-functional clinical teams.

Conducts remote and onsite clinical trial monitoring visits, including qualification, initiation, interim, and close-out visits. Ensures protocol, ICH GCP, FDA, regulatory, and SOP compliance; verifies source data and investigational product accountability; reviews regulatory documents; manages site issues, adverse event reconciliation, recruitment, and audit preparation. Supports monitoring plans, budgets, training, CTMS maintenance, CRA mentoring, sponsor communication, and cross-functional issue resolution.