What you will be doing:
CRA II is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications.
- Support project teams in the placement, implementation, communication, site management, recruitment and retention (R&R) issue identification and resolution, and activities required at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects.
- Track subject enrollment and identify R&R issues, maintain regular communication w/site staff. Document and communicate study site progress and issues/concerns to the project team.
- Assist other CRAs with study site issues/concerns/audits with the investigator and independently offer resolution strategies, documenting follow-up activities/outcomes.
- Lead or facilitate collaborative CRA efforts to meet company objectives by organizing/managing special data collection efforts, present or set up task force, as directed by CRM/CPL.
- Follow the Site Management / Ownership / Partnership model to monitor multiple Phase II, III & IV clinical trial sites, across therapeutic areas. Independently schedule and prioritize workload to meet projected deadlines.
- Provide adequate reporting and tracking of AEs, protocol deviations and subject status..
- Build regional territory by identifying and maintaining contact with potential (near or long term) research investigators.
- Expand understanding of regulations governing clinical research, beyond FDA regulations and ICH/GCP guidelines, (e.g. international regulatory procedures or high level of proficiency in a specific area, e.g. AE reporting) so as to be a resource for the CRA team.