Senior Clinical Research Associate

Job Description

We are currently seeking a Senior Clinical Research Associate. The role will report to either a Team Lead CRA, Senior Project Manager, or Head of Clinical Operations in Europe. Within the role you will be responsible for:

  • Supporting the Project Manager in the set-up of the Clinical Trials (Phase I to IV, as well as Non-Interventional Studies (NIS) or Investigator Sponsored Studies (ISS)) including:
    • Compilation of documents for submissions to ethics committees and regulatory authorities
    • Compilation of investigators' files according to given specifications
    • Filing and tracking of documents in the different files (trial master file and project file)
  • Creating prerequisites for study initiation
  • Recruitment of investigators
  • Organization of investigators' meetings
  • Performance of on-site visits when needed in limited cases
  • Preparation of status reports
  • Handling of investigators' payments
  • Assistance to PM as regards communications with
    • Authorities and IRBs/ECs
    • Institutions (e.g. hospitals, private practice)
    • Investigational sites
    • Participation in in-house audits and/or inspections as required
    • Sponsor
    • Vendor
  • CRF in-house-review, if required by Project Data Manager (PDM) and/or Clinical Data Coordinator (CDC)
  • Training on the job for new CRAs, CTAs and Project Assistants
  • Co-ordination of CRAs and individual steps of national or multinational multicentre trials and Quality Control of monitoring functions and supervision of GCP compliance as well as time lines
  • Participation in audits/inspections of investigational sites he/she is/was responsible for
  • Contribute to Business Development activities in agreement with Head Clinical Operations – e.g. requests for proposal, request for information and bid defense meetings

Desirable Skills and Experience

  • Minimum of 5 years CRA background
  • At least three years of monitoring experience as a CRA (training time included)
  • Successfully completed CRA follow-up training and achievement of a very good GCP test result certified by the NLS Training Department or equivalent proof of competence
  • Good knowledge of GCP principles and related European and national regulations
  • Excellent command of native language
  • Good command of written and spoken English
  • Basic knowledge of usual Office software

Moscow, Russia

Study of Natural Science (Biology, Chemistry), medicine, pharmacy, nursing, or similar

Associate

Clinical Research

Full Time

03 Nov 2021