Clinical Research Associate II (Novosibirsk, Siberia)

з/п не указана

Новосибирск

Требуемый опыт работы: 1–3 года

Полная занятость, полный день

Responsibilities:

Study Planning

  • Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
  • Assume ambassadorial role to facilitate communication between sites and the company to increase value proposition to investigators.
  • Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
  • Negotiate investigator remuneration; prepare financial contracts between company and investigational sites and investigators. Ensure adherence to payment schedule.

Study Start-up

  • Execute site initiation and training, generate initiation visit report.

Study Execution

  • Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes
  • Identify problems at sites; resolve issues and escalate as appropriate.
  • Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
  • Complete preparation and generation of visit monitoring reports as per relevant SOP
  • Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
  • If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues

Study Close-out

  • Implement site close-out activities and generate site close-out report.
  • Provide feedback on site performance for future trial site feasibility/selection

General

  • Improve skills by timely completion performance of assigned global and local training.
Requirements:
  • CRA II: Must have Minimum 2-3 years prior monitoring experience with global trial

Ключевые навыки

Английский — A1 — Начальный
MS Outlook
MS PowerPoint
MS Visio
Поиск информации в интернет
Clinical Research
GCP (Good Clinical Practice)
Study Termination (CRA)

Контактная информация

Вакансия опубликована 19 февраля 2021 в Новосибирске

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