Innovo Research Benefits Overview

Coordinates clinical research studies by recruiting and consenting participants, collecting and maintaining study data, performing clinical procedures, managing specimens and regulatory documentation, monitoring participant safety, resolving data queries, and supporting audits and inspections. The role ensures protocol, GCP, FDA, and quality requirements are followed while coordinating study visits, staff training, supplies, scheduling, and communication with investigators and research subjects.

Supports clinical trial execution through participant recruitment and screening, informed consent, study visits, patient care, phlebotomy, specimen handling, documentation, and regulatory compliance. Maintains case report forms, source documents, regulatory files, study supplies, calendars, and electronic records. Collaborates with investigators, providers, sponsors, and research staff while supporting monitoring visits, audits, study initiation, and closeout activities. The role is performed in person in a clinical environment with occasional travel to partner sites.

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.