Clinical Research Associate II (CRA II) - Home Based
DOCS
Buenos Aires, Argentina
hace 3 días
source : JobLeads

Clinical Research Associate II (CRA II) - Home Based

Ref # : 24470

Employment type : Permanent - Full-Time

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.
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