Covance

Clinical Research Associate - sponsor-dedicated

Company
Covance
Location
Germany
Salary
Competitive
Posted
06 Jan 2021
Closes
05 Feb 2021
Ref
10024_57555-germany
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Clinical Research Associate - sponsor-dedicated

Location: Munich, Germany / Home Office, Germany

Covance has supported the pharmaceutical industry worldwide in developing more medicines than any other company, including the top 50 best-selling drugs on the market today. Our highly dedicated, supportive teams work on bringing drugs to market that have a real impact on the lives and health of people.

If you are looking for a position in which you can leverage your monitoring expertise as much as your talent to connect and communicate with a wide variety of people while expanding your therapeutic know-how, this is the perfect opportunity. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, an attractive compensation package, great learning and career growth opportunities and the chance to work with some of the most innovative pharmaceutical companies in the world. Sounds exciting? Then we look forward to meeting you!

Your responsibilities will typically include:
  • Full responsibility for 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, independent source document review. Monitor data for missing or implausible data, generate and resolve queries against established data review guidelines
  • 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
  • Act as contact for clinical trial suppliers and other vendors
  • Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Depending on your experience, assist with training, mentoring and development of new employees, e.g. co-monitoring
Education/Qualifications:
  • Degree in a relevant field such as pharmacology, biology, life sciences, health care, (veterinarian) medicine, oecotrophology etc.
  • Alternatively an equivalent vocational education (e.g. study nurse, study coordinator) and / or professional experience as CRA
Experience:
  • Professional experience in clinical research, preferably in a CRO or a pharmaceutical company
  • Previous clinical monitoring experience in Germany, including familiarity with the applicable German regulations, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and the local regulatory authorities
  • Familiarity with relevant IT tools such as Microsoft Office, eTMF, CTMS, EDC
  • 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
  • Business fluency in German - both spoken and written - as well as a good command of English are a must

Remote #LI-AR1

Similar jobs

Similar jobs