Monroe+Biomedical+Research

The role involves entering clinical study data from the CRIO platform into sponsor EDC systems while ensuring accuracy and compliance. Responsibilities include verifying data against source records, resolving queries, and maintaining strict confidentiality of patient information.

The Director will identify and secure new clinical trial opportunities by building relationships with pharmaceutical companies, biotech firms, and CROs. They will collaborate with senior leadership to execute business development strategies and monitor ROI via a CRM system.

Assist with the preparation and submission of regulatory documents, including IRB submissions and amendments, while maintaining audit-ready electronic regulatory files. Support clinical study start-up activities and ensure compliance with FDA and ICH-GCP guidelines.

Manage the submission of feasibility questionnaires and maintain accurate sponsor and CRO database profiles. Support business development operations by tracking study leads and maintaining site capability records.