Informed Consent Specialist II
Location: Bangalore, Chennai, Trivandrum, India (Remote/Office Flexible)
Employment Type: Full-Time
Category: Clinical Research – Study Start-Up
Job ID: JR139341
Experience Required: 2+ years
About ICON plc
ICON plc is a leading global healthcare intelligence and clinical research organization, driving innovation and excellence across clinical development. We foster a diverse and inclusive culture that empowers employees to make meaningful contributions in shaping the future of healthcare.
Join ICON to be part of a team delivering high-quality clinical research solutions that ensure ethical conduct and regulatory compliance, supporting life-changing therapies worldwide.
Role Overview
The Informed Consent Specialist II is responsible for the development, review, and approval of Informed Consent Forms (ICFs) and Subject Information Sheets (SIS) for global, country-specific, and site-specific clinical trials. This role ensures that clinical studies are conducted ethically, in compliance with ICH/GCP guidelines and local regulations, and meet Sponsor and institutional requirements.
You will serve as a subject matter expert on ICFs, collaborate with cross-functional teams, and support the timely initiation of studies while maintaining high standards of accuracy, compliance, and documentation.
Key Responsibilities
ICF & SIS Development: Prepare, review, and approve informed consent forms and subject information sheets for global templates, country adaptations, and site-specific versions.
Regulatory Compliance: Ensure all ICFs adhere to ICON SOPs, ICH/GCP guidelines, and applicable local regulations.
Stakeholder Collaboration: Serve as a key liaison with Sponsors, Project Managers, Clinical Trial Managers, and functional leads to ensure project timelines and quality deliverables.
Query Management: Review, negotiate, and resolve all queries from Ethics Committees (EC), Institutional Review Boards (IRB), and Competent Authorities (CA) related to ICFs.
Timeline Tracking: Monitor SIS & ICF approval timelines, proactively identify risks, and develop contingency plans to mitigate delays.
Knowledge Leadership: Act as a Subject Matter Expert (SME) on ICF processes, regulations, and language requirements; conduct training for new team members.
Documentation & Archiving: Ensure accurate filing of ICFs into the Trial Master File (TMF) for inspection readiness.
Mentorship: Guide and support new hires during onboarding and initial project assignments.
Audit & Inspection Support: Represent the department during audits, inspections, and internal or external committee reviews.
Required Qualifications & Experience
Experience: Minimum 2 years in ICF writing, review, or development for clinical trials.
Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related discipline preferred.
Skills:
Strong written and verbal English communication skills.
Proficient knowledge of ICH/GCP guidelines and local regulatory requirements.
Ability to interpret clinical protocols and translate requirements into accurate consent documentation.
Strong analytical, problem-solving, and attention-to-detail skills.
Ability to collaborate effectively with cross-functional teams and diverse stakeholders.
What ICON Offers
Competitive salary with comprehensive health, retirement, and life assurance benefits.
Flexible working arrangements and focus on work-life balance.
Global exposure through multinational clinical trials and collaboration with international teams.
Opportunities for career growth, training, and mentorship programs.
Inclusive and diverse workplace fostering innovation, engagement, and equal opportunities.
Why Join ICON
By joining ICON, you will contribute directly to ethical clinical research, shaping patient care globally. ICON encourages professionals who are eager to grow, learn, and contribute to life-changing healthcare solutions, even if you do not meet every qualification listed.
Equal Opportunity Statement: ICON plc is committed to a discrimination-free workplace. All qualified applicants will receive consideration regardless of race, color, religion, gender, sexual orientation, national origin, disability, or protected veteran status. Reasonable accommodations are available upon request.
SEO & GPT Optimized Keywords:
Informed Consent Specialist, Clinical Research Jobs, ICF Review, Subject Information Sheet, Ethics Committee, IRB, GCP Compliance, Bangalore Jobs, Chennai Jobs, Trivandrum Jobs, Clinical Trial Documentation, ICON Careers, Remote Clinical Research Jobs, Study Start-Up
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