Jobs at Alira Health

Conduct and oversee site monitoring for clinical trials including initiation, interim, and close-out visits (remote and onsite), source data verification, eTMF/CRF review, investigational product accountability, SAE reconciliation, site training and mentoring, regulatory compliance (ICH GCP/FDA/local), study documentation, and collaboration with sponsors and cross-functional teams to ensure protocol adherence and data quality.

Responsible for independent site monitoring (initiation, monitoring, close-out), ensuring GCP/ICH compliance, managing ISF/TMF filing, IP accountability, safety event verification, site training, recruitment support, CRF/query resolution, and audit readiness. Collaborates with cross-functional teams and sponsors, prepares monitoring reports, and may manage study budgets for stand-alone projects. Frequent travel required to support on-site activities.

Conduct secondary and primary research on pharmaceutical and biotech markets, support data analysis and financial modeling, prepare deliverable sections, coordinate interviews, and contribute to proposals, recruiting, and knowledge management while building therapeutic and industry expertise.

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.

Lead clinical study implementation and act as primary sponsor contact. Manage study functions (supply, IWRS/IXRS, data management, biostatistics, PV, central lab), supervise and train clinical staff, create and review study documents, ensure ICH GCP/FDA compliance, support TMF, prepare for audits/inspections, report study status and billing, and drive timely attainment of trial milestones.

Lead CRA provides oversight and mentorship to CRA teams, ensures GCP and protocol compliance, conducts onsite/remote monitoring visits, reviews CRF/source data and regulatory binders, supports hiring/onboarding and billing, assists with CTMS and quality processes, and liaises with cross-functional teams to resolve site issues and support study conduct.

Conduct and oversee clinical trial site monitoring (qualification, initiation, interim, close-out) to ensure protocol, GCP, and regulatory compliance. Perform source data verification/CRF review, eTMF/TMF QC, investigational product accountability, SAE reconciliation, monitoring visit reporting, site training/mentoring, budget oversight for stand-alone studies, and cross-functional coordination with sponsors, data management, and finance.