Clinical Monitoring Specialist

4 days ago

Uxbridge, United Kingdom Parexel Full time
Job Description

Parexel is seeking a highly skilled Clinical Monitoring Specialist to join our team. As a Clinical Monitoring Specialist, you will be responsible for ensuring the integrity and quality of clinical data, as well as ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject.
  • Conduct source document review and verification of appropriate site source documents and medical records.
  • Verify required clinical data entered in the Case Report Form (CRF) is accurate and complete.
  • Manage reporting of protocol deviations and appropriate follow up.
  • Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
  • May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security.
  • Verify the IP has been dispensed and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP.
  • Apply knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returned.
  • Manage reporting of identified issues and manages follow up to resolution.
  • Document activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.
  • Ensure all activities are managed by site personnel who are appropriately delegated and trained.
  • Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Requirements:
  • Networking and relationship building skills. Ability to communicate effectively and appropriately with internal and external stakeholders.
  • Ability to adapt to changing technologies and processes. Effectively overcoming barriers encountered during the implementation of new processes and systems.
  • Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization.
  • Identifies and builds effective relationships with investigator site staff and other stakeholders.
  • Proficiency in local language is required.
  • Advanced level or fluency in English is required.
Education:

Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.

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