Teams at Alira Health

Manages clinical research studies from planning through completion, ensuring compliance with approved budgets, timelines, ICH GCP guidelines, and FDA regulations. Serves as the primary sponsor contact, leads cross-functional clinical teams, supervises and trains staff, oversees study documentation and trial milestones, manages subject accrual and retention, supports audits and inspections, prepares reports and billing information, and develops solutions to study issues.

Conducts qualification, initiation, interim, co-monitoring, and close-out visits for oncology clinical trials. Ensures protocol, ICH GCP, FDA, regulatory, and sponsor SOP compliance; verifies source data, manages investigational product accountability, reviews regulatory documentation, reconciles safety reports, and addresses site issues. The role supports monitoring plans, site training, recruitment, audits, budgets, CTMS activities, and CRA mentoring while collaborating with sponsors, investigators, data management, and project teams.

Conducts remote and onsite clinical trial monitoring visits, including qualification, initiation, interim, and close-out visits. Ensures protocol, ICH GCP, FDA, regulatory, and sponsor SOP compliance; verifies source data, maintains trial documentation, tracks investigational products, supports adverse-event reporting, and resolves site issues. Collaborates with sponsors, investigators, CRAs, data management, and project teams while assisting with monitoring plans, training, audits, budgeting, CRA mentoring, and CTMS activities.