Clinical Research Associate Manager

3 days ago

Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time
Job Description:
We are seeking a highly skilled Clinical Research Associate Manager to join our team at Fortrea. In this role, you will be responsible for managing clinical studies, ensuring the protection of study subjects, and safeguarding data integrity. 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.

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 a basic understanding of the clinical trial process are also required. The salary for this position is estimated to be around $80,000 - $110,000 per year, depending on location and experience.

Responsibilities:
- Site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements
- Conducts site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits
- Prepares and implements project plans related to Clinical Monitoring responsibilities
- Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements
- Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems
- Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial
- Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
- Ensures adherence to global quality control and CRA performance metrics
- Ensures audit readiness at site level
- Acts 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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