Core ICF Developer/Writer and Reviewer (Centralized role)

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 included within the Master Informed consent form during development and review

Supports the development, Review, and approval of master templates to ensure effective and timely execution of protocol/site activation

Create, review, and revise training material and plans to support the training requirements of the team.

Responsible for timely and appropriate communication to all stakeholders, as applicable

Liaise with PM/Designee to communicate any trends, outstanding issues, safety concerns, or any other activity or lack thereof that may jeopardize the clinical trial delivery or patient safety from the task assigned.

Skills:

Strong knowledge of the drug development process

Good understanding of FDA IND/NDA requirements

Strong understanding of regulations, policies, and procedures concerning the conduct of clinical trials including FDA regulations, biological samples regulations, GDPR, and GCP guidelines

Knowledge and understanding of medical terminology and health Literacy principles are a plus

Excellent customer service/ management skills

Computer skills with excellent proficiency in MS Word

Excellent command of the English language along with written and verbal communication skills

Ability to Influence stakeholders through insight into industry trends

Demonstrated ability to plan, prioritize, and deliver timely.

Demonstrated ability to pay attention to detail.

Ability to deliver consistently high-quality work.

Ability to negotiate with others.

Ability to mentor and train others

Ability to adapt to this fast-paced, dynamic environment

Requirements:

University/College Degree (medical degree preferred)

Previous experience in writing and editing master informed consent forms and other clinical trial-related documents (5 years or more)

Advanced English (Oral and Written)

Strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.

In addition to the above, Candidates without medical/life sciences background but with relevant domain knowledge and experience may be considered, if deemed appropriate for specific tasks and activities.

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