Core competencies include:
- Clinical Regulatory Strategy (in collaboration with RA).
- Feasibility, registrational, human factors and post-market study design (US, OUS) / protocol development.
- Case Report Forms (CRFs) / Electronic database capture (EDC) system development/management.
- Draft Informed Consent Forms (ICF), ICF process forms, recruitment materials, and other supporting ethics documentation.
- Ethics submission and oversight.
- Clinical Site Management (selection, budget, contracts, ethics, screening, enrollment, monitoring, study closure).
- Vendor management (e.g., EDC, reference labs, kit suppliers etc.).
- Data management.
- Data analysis, Clinical Trial Report writing, regulatory submissions, manuscript preparation and submission/management of publication of clinical trial findings (e.g., applicable registries / peer reviewed journals etc.).
- Essential document file management.
- Review of product labeling (package insert, product labels).
