Site Integrity Specialist
4 weeks ago
About the Role
Parexel is seeking a highly skilled Site Monitor to join our team in the UK. As a Site Monitor, you will be responsible for ensuring data integrity, data quality, and compliance with ICH GCP and local requirements at the site level.
Key Responsibilities
- Ensure regulatory, ICH-GCP, and protocol compliance by evaluating overall site performance and providing recommendations for site-specific actions.
- Verify the process of obtaining informed consent and assess factors that might affect subject safety and clinical data integrity.
- Conduct monitoring activities using different methods, such as on-site and remote monitoring, and verify required clinical data entered in the Case Report Form (CRF) is accurate and complete.
- Manage reporting of protocol deviations and follow up on issues or risks associated with blinded or randomized information related to Investigational Product (IP).
- Apply knowledge of GCP and local regulations to ensure IP is appropriately labeled, imported, and released and returned.
- Document activities via follow-up letters, monitoring reports, communication logs, and other required project documents.
- Ensure all activities are managed by site personnel who are appropriately delegated and trained.
Requirements
- Networking and relationship building skills to communicate effectively with internal and external stakeholders.
- Ability to adapt to changing technologies and processes.
- Excellent communication, presentation, and interpersonal skills.
- Proficiency in local language and advanced level or fluency in English.
- Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.
About Parexel
Parexel supports clinical studies across the full range of therapeutic areas and has longstanding partnerships with a vast client base. We enable more niche drug developments that are critical to the well-being of many patients.
What We Are Looking For
We look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.
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