Ref #: 24483

Employment type: Permanent - Full-Time

Location: Chile - Santiago

Posted: 06-Oct-2020

Description

• 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.