CRA II, Denmark

 Posted a month ago
     
2-5 years experience
Apply Now

Please mention DailyRemote when applying

AI Summary

Manage clinical trial sites by performing monitoring visits and ensuring patient safety and protocol adherence. Maintain data integrity through source data verification and oversee regulatory documentation and investigational product accountability.

This role is for upcoming future opportunities that may arise at Fortrea.

Join Fortrea as a CRA – exciting future opportunities across multiple sponsors

We’re excited to invite CRAs to join Fortrea, where you’ll work on a diverse portfolio of studies across multiple sponsors. This role offers strong exposure to different therapeutic areas, high-quality standards, and the opportunity to further develop your monitoring expertise in a global environment.

Key requirement:

  • Minimum 2 years of clinical monitoring experience

  • Preferably 1+ year experience in oncology studies

Summary of Responsibilities

  • Manage clinical trial sites in line with Fortrea SOPs, ICH GCP and sponsor requirements

  • Perform all monitoring visits (PSV, SIV, routine, close-out)

  • Ensure patient safety by verifying informed consent and protocol adherence

  • Maintain data integrity through SDV, query management, and data review

  • Keep site regulatory documentation and eTMF up to date

  • Oversee investigational product handling, storage, and accountability

  • Ensure audit readiness and compliance with quality standards and CRA metrics

  • Prepare monitoring plans, visit reports, and study documentation

On-site Monitoring Responsibilities

  • Ensure site staff are trained and equipped to run the study

  • Verify subject eligibility, consent, and protocol compliance

  • Review source data for accuracy and completeness

  • Identify and resolve data discrepancies and deviations

  • Perform efficient monitoring activities in line with SOPs and travel policy

  • Submit timely and accurate visit reports

  • Track study progress, IP shipments, and serious adverse events

  • Collaborate closely with study teams to meet timelines and deliverables

Additional Responsibilities

  • Support investigator/site management activities

  • Work with CTMS and other eClinical systems

  • Attend investigator meetings and project calls

  • Deliver site training and support onboarding of new team members

  • Contribute to study planning and monitoring strategy

Qualifications & Experience

  • Degree in life sciences or related field (or equivalent experience)

  • Strong knowledge of ICH GCP and clinical trial processes

  • Minimum 2 years of clinical monitoring experience

  • Ability to monitor independently with minimal supervision

  • Experience with SAE reporting and clinical data review

  • Strong organizational, problem-solving, and communication skills

Additional Information

  • Willingness to travel (~60% to study sites)

Learn more about our EEO & Accommodations request here.

Similar Jobs

See all Remote Others jobs →

Personalize your Remote Job Search in 3 Easy Steps!

Discover remote opportunities in Others

Answer easy questions

Answer easy questions

200,000+ jobs across 15+ categories

Get your best job matches

Get your best job matches

Only hand-screened, legit jobs

Find a remote job faster

Find a remote job faster

No ads, scams, or junk

I was the first applicant for a remote marketing position that got listed on the company website the same day I applied. Had an interview within 48 hours!

Sarah J. — Sarah J. · Marketing Manager ★★★★★ Verified