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 safeguarding data integrity
- Preparing and implementing project plans related to clinical monitoring responsibilities
- 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)
- A minimum of 2 years of clinical monitoring experience
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Fluent in local office language and English, both written and verbal
- Good planning, organisation, and problem-solving abilities
Preferred qualifications include:
- Life Science or Nursing qualification
- Phase I monitoring experience
- Experience using e-clinical systems (e.g., CTMS)
- Good analytical and negotiation skills
In return, we offer a competitive salary and benefits package.
The role involves sitting at a computer for long periods, using hands to finger, handle or touch objects, tools or controls, and may require outside of normal office hours.
Travel Requirement is 60% of the time (travelling to study sites).