(Senior) Clinical Research Associate (s)CRA - sponsor-dedicated
Covance Inc
Bucharest, Romania
6 zile în urmă

Job Overview :

Senior) Clinical Research Associate (s)CRA - sponsor-dedicated

Location : Home Office, Romania

A formula for clinical innovation : Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas.

In this role, you will work directly with one of our renowned key sponsors and advance the development of innovative, life-changing medications for oncological therapies.

What we have to offer : a strong international support network, flexible working solutions that facilitate a genuine work-life balance, excellent career opportunities, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, we are looking forward to meeting you!

As (Senior) Clinical Research Associate, you typically will :

  • Own all aspects of site management as described in the project plans
  • Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study
  • Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
  • Monitor data for missing or implausible entries

  • Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports
  • Review progress of projects and initiate appropriate actions to achieve target objectives
  • Interact with internal work groups to evaluate needs, resources and timelines
  • Act as contact for clinical trial suppliers and other vendors as assigned
  • Own the entire process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow ups on SAEs
  • Independently perform CRF reviews
  • Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems
  • Assist with training, mentoring and development of new employees, e.g. co-monitoring
  • Education / Qualifications :

  • Degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, oecotrophology etc.
  • In lieu of the above, a completed equivalent vocational education (e.g. study nurse, research nurse, study coordinator.
  • and / or equivalent professional experience
  • Experience :

  • Proven experience in clinical research in a variety of therapeutic areas including oncology
  • Solid independent monitoring experience in Romania as (Senior / Lead) CRA and familiarity with applicable local regulations and authorities
  • Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the Romanian regulatory authorities landscape
  • Working knowledge of Microsoft Word, Excel and PowerPoint
  • Effective time management and organizational skills and a keen attention to detail
  • Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
  • Excellent communication skills in both Romanian and English - spoken and written - are a must
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