Teams at Alira Health

Conduct site monitoring activities for clinical trials including initiation, interim, and close-out visits; ensure protocol/GCP compliance, source/CRF verification, SAE reconciliation, regulatory binder review, investigational product accountability, query resolution, audit prep, and reporting. Collaborate with in-house CRAs, project managers, and sponsors to support site performance and enrollment.

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.