Description
We are seeking a Clinical Research Associate to manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
The successful candidate will be responsible for site management, monitoring, and ensuring compliance with regulations and guidelines.
Key responsibilities include:
- Conducting site monitoring visits, including pre-study, initiation, process monitoring, routine monitoring, and close-out visits
- Verifying study training records and ensuring site regulatory documents are complete and current
- Ensuring the protection of subjects and data integrity through careful source document review and query generation
- Preparing and implementing project plans and study-specific monitoring plans
- Working closely with the study team to ensure study deliverables are met
- Travel to study sites, which may include international travel, is required (approximately 60% of the time)
The ideal candidate will have:
- A university or college degree in a related allied health profession (e.g., nursing licensure)
- At least 2 years of clinical monitoring experience
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Excellent organisational, problem-solving, and communication skills
- Ability to work independently and as part of a team
Preferred qualifications include:
- Experience with Fortrea SOPs for site monitoring
- Additional years of experience in a related field (e.g., medical, clinical, pharmaceutical)
- Phase I monitoring experience
- Life Science or Nursing qualification
- Specific skills, systems, certifications, and/or licenses
We offer a competitive salary and benefits package.