Innovo Research Benefits Overview

Manages centralized regulatory operations across clinical research sites, including electronic regulatory binders, IRB submissions, informed consent forms, study-startup documents, training records, and audit readiness. Serves as a liaison for monitoring and site visits, supports inspections, assesses regulatory risks, and trains internal teams on protocol requirements. Requires knowledge of FDA regulations, ICH guidelines, and GCP standards, along with strong organization and communication skills.

Coordinates clinical research studies by recruiting and consenting participants, scheduling visits, collecting and maintaining study data, performing clinical procedures, managing specimens, monitoring safety, resolving data queries, and maintaining regulatory documentation. Supports investigators during study execution, audits, inspections, and monitoring visits while ensuring compliance with protocols, SOPs, GCP, FDA regulations, and quality standards. The role also trains site staff, manages supplies, coordinates coverage, and collaborates with provider offices.

Supports clinical trial operations from initiation through closeout, including participant recruitment, eligibility screening, informed consent, study visits, patient care, phlebotomy, specimen handling, documentation, regulatory compliance, and audit support. Maintains case report forms, source records, regulatory files, inventories, schedules, and electronic research systems. Collaborates with investigators, providers, sponsors, patients, and research staff while ensuring adherence to GCP, FDA, HIPAA, protocol, safety, confidentiality, and data-integrity requirements.