Clinical Research Associate in Copenhagen

at  LINK Medical

• Denmark
  Are you interested in clinical research and working in close collaboration with members of internal and external project teams, with local and external international projects, this might be the right opportunity for you.
  LINK Medical Research is searching for a highly motivated fulltime CRA at our office in Copenhagen, Denmark. As a CRA, you will work in close collaboration with members of internal and external project teams, with local and international projects, and within a range of different therapeutic areas.
  You may also be outsourced to clients in the greater Copenhagen area and the position will involve frequent travelling related to monitoring visits.

DESIRED QUALIFICATIONS

• Basic education within relevant field, equivalent to degree from University or University level. Formal education may be compensated by experience.
• Ability and desire to fulfil our customer promises: Quality, punctuality and communication.
• Up to date on ICH-GCP including national regulatory requirements
• Experienced in monitoring studies or running clinical studies and in investigator site management
• Must be fluent in Danish (required) and English
• Good writing skills in both Danish and English
• Generally good IT skills and use of standard office tools

Personal Characteristics

• Service minded with good cooperation and communication skills, as well as oral and written presentation skills
• Well organized and structured, able to work both independently and in teams
• Independent, flexible, accurate, and solution oriented

• Complete clinical monitoring and site management tasks according to the protocol, ICH-GCP/ISO 14155, Standard Operating Procedures (SOPs) and applicable regulations
• Perform Source Data Verification (SDV) and review of Case Report Forms (CRFs)
• Document all monitoring visits by completing the relevant report in a timely manner
• Preparation, handling and distribution of clinical study supplies and products when applicable
• Comply with applicable timelines, agreements and budget
• Manage and perform monitoring and site management activities related to clinical trials of all phases (I-IV) and in all stages;
• Planning
• Initiation/Set-up
• Conduct
• Close-out
• Plan and organize investigator meetings
• Complete or contribute to EC/IRB and CA applications
• Develop and use study specific material
• Training of study staff and other LINK Medical employees
• Develop training material and conduct internal and external courses