Site Monitoring Specialist Lead

3 days ago


Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time
Job Title: Site Monitoring Specialist Lead
We are seeking a highly experienced Site Monitoring Specialist Lead to lead our site monitoring efforts at Fortrea. As a leading global contract research organization, we offer a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. The estimated salary for this position is around $100,000 - $130,000 per year, depending on location and experience.

About the Role:
The successful candidate will have a university or college degree, or certification in a related allied health profession from an appropriately accredited institution. A thorough understanding of ICH GCP Guidelines and local regulatory requirements is essential. Experience in clinical monitoring and the clinical trial process, as well as leadership skills, are also required. The successful candidate will be responsible for leading site monitoring efforts, ensuring data integrity, and protecting study subjects.

Responsibilities:
- Lead site monitoring efforts according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans
- 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 informed consent procedures and protocol requirements are adhered to
- Safeguard data integrity through source document review, verification, query generation, and resolution
- Confirm Site Regulatory documents and eTMF/Sponsor Documents are complete and current
- Guarantee accurate study Investigational Product inventory and accountability, and secure storage of study materials
- Ensure adherence to global quality control and CRA performance metrics
- Ensure audit readiness at site level
- Act in the project role of a Lead CRA as assigned

Preferred Qualifications:
- Thorough working knowledge of Fortrea SOPs for site monitoring
- One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
- Phase I monitoring experience
- Life Science or Nursing qualification
- Specific skills, systems, certifications, and/or licenses preferred
- Personal characteristics (leadership, problem solving, interpersonal skills)
- Methodical approach to work
- Good understanding of medical and clinical research terminology and clinical research processes
- An understanding of the basics of physiology, pharmacology, and medical devices (when applicable)
- Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements
- Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
- Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.

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