Teams at Evolution Research Group

Manages clinical research projects from start-up through completion, overseeing scope, budgets, timelines, study materials, vendors, sites, regulatory compliance, data review, reporting, and client communications. Leads multidisciplinary internal and external teams, develops protocols and clinical documents, reviews monitoring reports, supports inspections, and ensures deliverables meet contractual, protocol, SOP, and quality requirements. The role is fully remote with occasional off-site meetings and conferences.

The TMF Specialist manages, reviews, approves, and files clinical trial documents in the eTMF. Responsibilities include validating metadata and version control, maintaining Expected Documents Lists, monitoring completeness, supporting audit readiness, resolving document discrepancies, coordinating with stakeholders, and ensuring compliance with SOPs, GCP, ICH guidelines, and TMF standards.

Supports clinical operations by organizing and quality-checking trial master files, preparing regulatory and study documents, coordinating meetings and training, tracking site activity, enrollment, monitoring reports, and study progress, and entering clinical data. The role assists with study drug release, investigator meetings, site communications, shipments, and issue escalation while ensuring compliance with SOPs, FDA regulations, and ICH/GCP guidelines.