Teams at Alira Health

Manages clinical research studies from implementation through completion, ensuring compliance with approved budgets, timelines, ICH GCP guidelines, FDA regulations, and company SOPs. Serves as the primary sponsor contact, coordinates clinical functions and vendors, supervises clinical staff and Associate Project Managers, oversees study documentation and reporting, manages accrual and retention, supports audits and inspections, and communicates study status, risks, and milestones to stakeholders.

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.