Senior Clinical Research Associate

6 days ago

Athens, Attica, Greece CORONIS Research S.A. Full time €35,000 - €60,000 per year

We are expanding our clinical operations team and we're currently looking for Senior Clinical Research Associates (Sr. CRAs) to join us

The Sr. CRAs will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects and to ensure they are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Primary responsibilities:

  • Supporting the development of clinical management plan and associated study documents as well as patient recruitment & retention plans
  • Managing progress by tracking regulatory submissions, recruitment, sites' compliance, case report form (CRF) completion, and data query resolution
  • Ensuring regulatory compliance of investigational sites with SOPs and ICH-GCP guidelines
  • Performing site selection, initiation, monitoring and close-out visits (on-site or remotely), according to study's monitoring guidelines, SOPs, ICH-GCP and any other applicable Guidelines
  • Collection, maintenance and updates of study documentation throughout the study
  • Reporting to the sponsor/client and preparing evaluative reports and/or other study-related communications according to the applicable requirements
  • Identifying and informing the Clinical Project Manager of concerns related to quality of the clinical study.
  • Acting as a primary liaison between the investigational sites, the Sponsor, the Clinical Project team and study site personnel
  • Performing appropriate clinical and project specific trainings to the CRAs
  • Participating in audits/inspections as well as facilitating their conduct
  • Preparation of and attendance to Investigator Meetings

Qualification requirements:

  • University degree in life sciences, pharmacology, biology or chemistry
  • At 4 years of previous demonstrated experience in the clinical field, including experience in clinical monitoring (pre-study, initiation, routine monitoring and closeout visits).
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Excellent command (written and verbal) of English language and proficient knowledge of medical terminology
  • IT literacy (MS Windows, MS Office, Internet Use)
  • Solid understanding of the drug development process and pharmaceutical legislation
  • Excellent organizational, prioritizing and communication skills
  • Ability to manage multiple and varied tasks with attention to detail
  • Effective time management to ensure project deadlines are met
  • Ability to manage required travel of up to 40% on a regular basis

If you are interested in this new professional challenge, we are looking forward to receiving your application. Please send your complete application documents in English or Greek to

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