Jobs at Alira Health

Supports clinical trial sites from approval through close-out without frequent travel. Responsibilities include preparing study and regulatory documents, supporting IRB submissions, ensuring site approvals, reviewing trial files and eCRF data, resolving queries, monitoring protocol and GCP compliance, training sites, assessing performance and accrual, and collaborating with field CRAs, data management, sponsors, and project managers.

Senior In-house Clinical Research Associates manage clinical sites from approval through close-out with limited travel. Responsibilities include preparing study and regulatory documents, supporting IRB submissions, ensuring site compliance with ICH GCP and FDA regulations, reviewing trial files and eCRF data, resolving data queries, training sites, monitoring performance and accrual, and collaborating with field CRAs, data management, sponsors, and project teams.

Supports clinical trial sites from approval through close-out without frequent travel. Responsibilities include preparing study and informed consent documents, supporting IRB submissions, maintaining regulatory files and the Trial Master File, reviewing remote eCRF data, monitoring protocol and GCP compliance, resolving data queries, training sites, assessing performance and enrollment, and collaborating with field CRAs, data management, sponsors, and project teams.

Supports consulting and research engagements for global healthcare clients through secondary research, quantitative and qualitative analysis, stakeholder interviews, evidence synthesis, and preparation of presentations, reports, models, proposals, and client communications. The Analyst collaborates with cross-functional teams on market access, pricing, patient engagement, real-world evidence, and health economics projects while developing knowledge of global healthcare systems.

Lead corporate clinical development operations and cross-functional teams to execute clinical trials and advance the development pipeline. Oversee clinical, nonclinical, regulatory, quality, CMC/manufacturing, and program management functions, ensure regulatory compliance (GCP/GLP/GMP/ICH/FDA), manage external CRO/CDMO partnerships, and drive operational strategy, budgeting, and risk mitigation. Serve on the Executive Leadership Team and support investor, board, and business development activities.

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.

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.

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.

Conducts remote and onsite clinical trial monitoring visits, including site qualification, initiation, interim, and close-out visits. Ensures protocol, ICH GCP, FDA, regulatory, ethical, and SOP compliance; verifies source data, manages investigational product accountability, reviews regulatory documents, supports recruitment, resolves site issues and data queries, and prepares monitoring reports. The role also supports monitoring plans, audits, budgets, CTMS activities, CRA training, mentoring, and sponsor-site communication.