CRA, Denmark

The IQVIA FSP team are changing the life science industry through inspired innovation. Our people make a difference. You could be part of a team that work on exciting complex studies for one single sponsor dedicated program! We are looking for a CRA who cares and wants to make a difference in the life science industry.

Responsibilities and duties

  • Working as a CRA you would act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
  • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
  • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  • Gains an in-depth understanding of the study protocol and related procedures.
  • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
  • Participates & provides inputs on site selection and validation activities.
  • Performs remote and on-site monitoring & oversight activities.
  • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. 
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
  • Qualifications/Skills

  • Must have minimum of 1 year onsite monitoring experience
  • Life science degree / relevant work experience
  • Strong knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Good therapeutic and protocol knowledge as provided in company training.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  • Problem solver
  • Organizational and problem-solving skills.
  • Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
  • #CRASDAJD


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    Når du tilmelder dig accepterer du samtidig vores privatlivspolitik. Du kan altid trække dit samtykke tilbage.