Job Title: Informed Consent Specialist
Location: Bangalore / Trivandrum / Chennai, India (Office or Home)
Company: ICON plc
Employment Type: Full-time
Salary: ₹6 LPA – ₹10 LPA (Estimated)
Job Description
ICON plc is seeking an Informed Consent Specialist to support clinical trial documentation and compliance activities. In this role, you will be responsible for preparing, reviewing, and approving Informed Consent Forms (ICFs) and Subject Information Sheets (SIS) to ensure regulatory compliance and ethical standards in clinical research.
You will collaborate with global stakeholders, manage approval timelines, and ensure accurate documentation for clinical trials while maintaining compliance with ICH-GCP guidelines and country-specific regulatory requirements.
Key Responsibilities
Prepare, review, and approve Informed Consent Forms (ICFs) and Subject Information Sheets (SIS) for global and country-specific clinical trials.
Ensure compliance with ICON SOPs, ICH-GCP guidelines, and applicable regulatory requirements.
Act as a key contact for Sponsors, Clinical Trial Managers, and Study Start-Up teams.
Review and respond to Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to ICF documentation.
Forecast and track ICF approval timelines, identifying risks and implementing mitigation strategies.
Ensure proper documentation and archiving within the Trial Master File (TMF).
Provide training and mentorship to new team members.
Represent the department during audits, inspections, and regulatory meetings.
Required Qualifications
Minimum 2 years of experience in ICF writing or development.
Strong English writing and communication skills.
Knowledge of ICH-GCP guidelines and informed consent regulatory requirements.
Ability to collaborate with cross-functional teams in a global environment.
Strong analytical and problem-solving abilities with attention to detail.
Experience in protocol interpretation and review is preferred but not mandatory.
Skills & Competencies
Strong understanding of clinical trial documentation and regulatory compliance.
Excellent technical writing and document review skills.
Ability to manage multiple projects and timelines simultaneously.
Strong stakeholder communication and collaboration skills.
High attention to detail and organizational ability.
Benefits
Employees at ICON plc may receive benefits such as:
Competitive salary and performance-based incentives
Health insurance for employees and families
Retirement and savings plans
Employee assistance programs and wellness support
Flexible benefits including childcare support, travel passes, and gym memberships
Paid leave and work-life balance initiatives
About the Company
ICON plc is a leading healthcare intelligence and clinical research organization that supports pharmaceutical, biotechnology, and medical device companies in developing innovative therapies and advancing clinical research worldwide
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