Job Summary
The Informed Consent Form (ICF) Reviewer supports clinical studies by reviewing, editing, and finalizing ICF templates prepared by study teams or CRO partners, ensuring they are compliant, participant-focused, and ready for study use. The role serves as a key point of coordination across study teams, CROs, and internal stakeholders, helping ensure consent documents meet quality and timeline expectations throughout study startup and maintenance.
Summary of the Essential Functions of the Job:
ICF Review & Compliance
- Review, edit, and finalize global, country, and site-specific ICF templates for clinical studies.
- Ensure ICF content is accurate, complete, protocol-aligned, and compliant with ICH-GCP, FDA, EUCTR, and other applicable country regulations, ethical guidelines, sponsor requirements, and participant comprehension standards.
- Apply plain-language and health literacy principles (e.g., targeted reading-grade level, readability tools such as Flesch-Kincaid) to ensure ICFs are comprehensible to participants with varying literacy levels.
- Identify and resolve ICF quality issues, inconsistencies, and compliance concerns, tracking progress of reviews and escalations and escalating complex issues as appropriate.
- Support the development, maintenance, and continuous improvement of ICF templates, guidance documents, training materials, and review processes to enhance quality, efficiency, and consistency.
Coordination & Communication
- Co-manage maintenance of the centralized Informed Consent Form mailbox.
- Coordinate cross-functional review and approval of ICF language with stakeholders including Clinical Operations, Regulatory Affairs, Legal, Privacy, Medical Writing, Translational Sciences, and CRO partners.
- Communicate effectively with internal stakeholders and external partners regarding ICF requirements, review status, and issue resolution.
- Maintain metrics and assist with reporting KPIs related to ICF review activities, quality, and turnaround times.
Prioritization & Responsiveness
- Manage multiple ICF review assignments simultaneously while balancing competing priorities and study startup deadlines.
- Respond effectively to expedited review requests and urgent study needs while maintaining quality, accuracy, and compliance standards.
- Demonstrate flexibility in adapting to changing priorities, evolving study requirements, and accelerated project timelines.
- Support critical business needs by providing timely reviews and recommendations in a fast-paced, deadline-driven environment.
Additionally, provide support to R&D Budget & Contracts activities and departmental initiatives, as assigned.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Minimum of two years working with Informed Consent Forms.
- Preferred knowledge of ICH-GCP, FDA, EU CTR, and other applicable country regulations governing informed consent.
- Excellent writing and editing skills, with the ability to translate complex, technical, or legal information into clear, patient-friendly language.
- Experience with conflict resolution.
- Proven ability to effectively manage change.
- Self-starter who works independently, proactively identifies issues, and proposes solutions.
- Detail oriented.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Proficiency with all applications of Microsoft Office.
- Good interpersonal skills.
- Comfort with ambiguity; ability to act without having the total picture
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
