• Region: Sweden
  • Perform feasibility, site identification, selection and evaluation, preparing/supporting initial list of sites and recruitment targets
  • Provides protocol and related study training to assigned sites.
  • Conducts monitoring (pre-study, initiation, routine monitoring and closeout) visit per monitoring plan and applicable SOPs
  • Conducts co-monitoring visits, if required
  • Completes monitoring visit reports in accordance with ICH-GCP, standards and SOP
  • Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
  • Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
  • Ensure inspection readiness of the study and sites
  • Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
  • Attends disease indication project specific training and general CRA training as required
  • Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
  • Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
  • Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.


  • At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
  • Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
  • Fluent in English and Swedish (writing and speaking)

Additional Information

This role is home based in Sweden and offers the option to work at a fast growing medium sized pharmaceutical sponsor, holding an outstandingly impressive development pipeline paired with a great work culture.