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.
Responsibilities:
- Conduct site monitoring responsibilities for clinical trials, including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits
- Prepare and implement project plans related to Clinical Monitoring responsibilities
- Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to
- Safeguard data integrity by reviewing source documents, generating queries, and resolving issues
- Confirm site regulatory documents and eTMF/Sponsor documents are complete and current
- Ensure adherence to global quality control and CRA performance metrics
- Travel to study sites, which may be required up to 60% of the time
Requirements:
- University or college degree in a related allied health profession (e.g., nursing licensure)
- 4-5 years of Clinical Monitoring experience
- Previous experience working with Oncology projects
- Fluent in English and local office language
- Ability to work with minimal supervision
- Understanding of Serious Adverse Event (SAE) reporting and process production
Preferred Qualifications:
- Thorough working knowledge of Fortrea SOPs for site monitoring
- Experience in a related field (e.g., medical, clinical, pharmaceutical, laboratory, research, data analysis)
- Phase I monitoring experience
- Life Science or Nursing qualification
- Specific skills, systems, certifications, and/or licenses preferred
Physical Demands/Work Environment:
- Must be able to sit at a computer for long periods
- Must be able to use hands to finger, handle or touch objects, tools or controls
- Standard office and/or home working environment
- Clinical Research Unit and hospital environment (administrative only)
- Risk of eye strain
- Will involve outside of normal office hours as required by the role