Apply for Informed Consent Specialist II at ICON India. Remote or office roles available in Bangalore, Trivandrum, and Chennai.
Company: ICON plc
Location: Remote (India) – Bangalore, Trivandrum, Chennai
Job Type: Full-Time
Experience: Minimum 2 years in ICF writing/development
Qualification: Life Sciences, Pharmacy, Nursing, or related fields preferred
Application Mode: Online
About ICON plc
ICON plc is a global leader in healthcare intelligence and clinical research, delivering innovative solutions to the life sciences industry. With a mission to advance clinical development and improve patient outcomes, ICON combines scientific expertise, regulatory knowledge, and cutting-edge technology to accelerate drug development programs worldwide. Work From Home Informed Consent Specialist II
ICON is known for its inclusive work culture, commitment to innovation, and dedication to employee development. The company fosters an environment where employees can grow professionally while contributing to the ethical and efficient conduct of clinical trials across the globe. Work From Home Informed Consent Specialist II
Position Overview – Informed Consent Specialist II
ICON is seeking an experienced Informed Consent Specialist (ICF Specialist II) to join its dynamic, global team. The position is remote-friendly and available in Bangalore, Trivandrum, and Chennai. Work From Home Informed Consent Specialist II
The Informed Consent Specialist ensures the accuracy, compliance, and timely approval of Informed Consent Forms (ICFs) for clinical trials. These forms are critical in obtaining proper informed consent from participants, ensuring ethical standards and regulatory compliance are maintained throughout the trial process.
This role is ideal for professionals with ICF writing or review experience and a strong understanding of ICH/GCP guidelines and country-specific regulatory requirements.
Key Responsibilities
1. ICF Development and Review
- Prepare, review, and approve Informed Consent Forms (ICFs) and Subject Information Sheets (SIS).
- Manage global master templates, country-specific adaptations, and site-specific versions.
- Ensure that all documentation is accurate, compliant, and ethically sound.
2. Compliance and Regulatory Oversight
- Apply expertise in ICON SOPs, ICH/GCP guidelines, and local regulatory requirements for informed consent.
- Ensure all ICFs meet global and local ethical and regulatory standards.
- Review and resolve queries from Ethics Committees (ECs), Institutional Review Boards (IRBs), and Competent Authorities (CAs) efficiently.
3. Stakeholder Collaboration
- Serve as a key contact for Sponsors, Clinical Trial Managers, Project Managers, and functional leads.
- Ensure effective communication to optimize project performance and timely approvals.
- Provide guidance and clarification on ICF content, regulatory requirements, and country-specific practices.
- Work From Home Informed Consent Specialist II
4. Timeline Management and Risk Mitigation
- Forecast, track, and manage approval timelines for SIS and ICFs.
- Identify risks proactively and develop contingency plans to minimize delays.
- Ensure timely submission and approval of ICFs for clinical trial initiation.
5. Subject Matter Expertise and Knowledge Leadership
- Act as a Subject Matter Expert (SME) on assigned ICF topics.
- Stay updated with regulatory changes, language requirements, and global best practices.
- Develop and deliver training sessions to team members and new hires.
6. Documentation and Archiving
- Ensure accurate, complete, and compliant transfer of ICFs into the Trial Master File (TMF).
- Maintain organized and auditable documentation in accordance with ICON and regulatory standards.
7. Mentorship and Representation
- Mentor and coach new team members during onboarding.
- Represent the department during audits, inspections, committees, and cross-functional work groups.
Required Qualifications and Skills
- Minimum 2 years of experience in ICF writing, review, or development.
- Strong English writing and communication skills.
- Proficiency in ICH/GCP guidelines and applicable local country regulations for informed consent.
- Ability to collaborate effectively with global and cross-functional teams.
- Strong analytical, problem-solving, and attention to detail skills.
- Experience with protocol review and interpretation is preferred but not mandatory.
- Work From Home Informed Consent Specialist II
What ICON Offers
ICON values the quality and expertise of its people. The company fosters a diverse and inclusive culture that rewards performance and nurtures talent. Work From Home Informed Consent Specialist II
Benefits Include:
- Competitive salary packages in line with industry standards.
- Flexible remote or office work options across India.
- Generous annual leave entitlements and paid time off.
- Health insurance coverage for employees and dependents.
- Retirement planning options and financial benefits to support long-term security.
- Access to the Global Employee Assistance Programme (TELUS Health) for wellbeing and mental health support.
- Life assurance and optional benefits such as childcare vouchers, gym memberships, and subsidized travel passes.
- Opportunities for professional growth, global exposure, and cross-functional collaboration.
Culture and Inclusion at ICON
ICON is committed to inclusion, diversity, and belonging. The company provides an accessible and discrimination-free work environment for all candidates and employees. Work From Home Informed Consent Specialist II
- Equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, disability, or veteran status.
- Support for reasonable accommodations during the application process or in performing essential functions.
- Encouragement to apply even if you do not meet all listed qualifications, as ICON values potential and transferable skills.
How to Apply
Interested candidates can apply through the official ICON careers portal: Work From Home Informed Consent Specialist II
👉 Apply Online for Informed Consent Specialist II (Insert official application link)
Application Deadline: Open until filled
Locations: Remote work available from Bangalore, Trivandrum, Chennai
Job Type: Full-Time
Conclusion
The Informed Consent Specialist II role at ICON plc is an outstanding opportunity for clinical research professionals seeking to advance their careers in clinical trial operations, regulatory compliance, and ethical research. This position offers exposure to global clinical trials, collaboration with international teams, and the chance to play a key role in ethical research conduct. Work From Home Informed Consent Specialist II
By joining ICON, you will contribute directly to high-quality clinical research, help ensure patient safety and regulatory compliance, and gain opportunities for professional growth and international experience.
If you are detail-oriented, collaborative, and passionate about clinical research ethics and informed consent, this is the perfect role to apply for today. Work From Home Informed Consent Specialist II
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