Clinical Research Associate II (CRA II) - Home Based
Ref # : 24470
Employment type : Permanent - Full-Time
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.
Provide the following support as directed by the CRM / CPL : assist in field monitoring training; conduct and observe site visits during training period;
offering experienced counsel on issues related
to SOPs, regulations and resolution tactics for site issues / concerns.
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.
Among other projects and activities.
Minimum 2 years industry experience as a CRA, or equivalent
Health related background and BS Degree required.
Advanced English is a MUST.