Core ICF Developer/Writer and Reviewer

Tasks:

Responsible for developing, reviewing, finalizing, and maintaining clinical trial documents such as informed consent forms.

Applies knowledge of GCP Guidelines, regulatory requirements, regulatory framework of privacy standards and biological samples standards, therapeutic area(s), and Investigational Medicinal Products (IMPs) to review and develop Informed Consent Forms (ICF).

Ensures that the content of the Master Informed Consent Form is consistent with the corresponding protocol and fully informs the subject of all information about the research study that a potential research subject will need to know to decide if they want to enroll in the study.

Ensures that research participants can easily understand the content and the scientific and medical language of the consent form.

Ensures that documents are written/edited in compliance with the global industry standards

Ensures client-specific guidance and requirements are incl...