Clinical Research Associate (CRA) II - sponsor-dedicated
Labcorp Drug Development
Bucharest, Romania
4 zile în urmă

Job Overview :

Clinical Research Associate (CRA) II - sponsor-dedicated

Location : Bucharest, Romania / Home Office, Romania

In this role, you will work directly with one of our renowned key sponsors, supporting them and your assigned study sites during phase I - III of clinical trials.

You will have a direct impact on the development of innovative medications, improving the lives and health of patients every day.

If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world class pharmaceutical working environment, this is an excellent opportunity!

What we have to offer :

  • flexible working hours, capped overtime and compensatory time off in lieu
  • 100% home-based, permanent employment contract
  • travel time work time
  • highly competitive compensation packages
  • regular, merit-based salary adjustments
  • lunch allowances on work days
  • extensive medical coverance under our insurance plan
  • excellent training and career development opportunites as well as support with furthering your education
  • strong support from Line Management and more than 20'000 colleagues worldwide
  • the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years
  • Your main responsibilities :

  • Perform required monitoring tasks at your study sites in an efficient manner, according to SOPs and established guidelines;
  • prepare accurate and timely trip reports and own all aspects of study 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 diligently reviewing source documents and monitoring the data for missing or implausible entries
  • Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems
  • Act as a central point of contact for clinical trial suppliers and other vendors supporting your studies
  • Own the entire process of Serious Adverse Event (SAE) reporting pertaining to your studies
  • Education / Qualifications :

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

    Experience :

  • Professional independentg site monitoring experience as a Clinical Research Associate
  • Experience in one or more of these therapeutic areas : diabetes, cardiovascular, inflammatory diseases, oncology
  • Familiarity with applicable Romanian and international regulatory requirements such as GCP / ICH
  • 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 diverse internal and external stakeholders
  • Business fluency in Romanian - both spoken and written - as well as a good command of English are a must
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