Informed Consent Specialist (ICF Specialist)
Job Title: Informed Consent Specialist (ICF Specialist)
Location: Bangalore, Chennai, or Trivandrum, India
Work Model: Office With Flex
Employment Type: Full-Time
Job Requisition ID: JR146421
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and therapies that improve patient lives worldwide.
Guided by its values of Integrity, Collaboration, Agility, and Inclusion, ICON supports pharmaceutical, biotechnology, and medical device companies throughout the clinical development lifecycle while maintaining the highest standards of ethics, quality, and regulatory compliance.
Position Overview
ICON is seeking an experienced Informed Consent Specialist (ICF Specialist) to join its Study Start-Up and Regulatory Operations team. This role is responsible for the development, review, approval, and management of Subject Information Sheets (SIS) and Informed Consent Forms (ICFs) used in global clinical trials.
The successful candidate will ensure that informed consent documentation meets regulatory, ethical, and sponsor requirements while supporting study startup timelines and maintaining compliance with international and local regulations.
This position plays a critical role in protecting participant rights, ensuring ethical clinical research conduct, and enabling successful study activation.
Key Responsibilities
Informed Consent Form (ICF) Development & Review
Prepare, review, and approve:
Global Master ICF Templates
Country-Specific ICFs
Site-Specific ICF Adaptations
Subject Information Sheets (SIS)
Ensure informed consent documents are accurate, clear, patient-friendly, and compliant with applicable regulations.
Support updates and revisions based on protocol amendments and regulatory requirements.
Regulatory Compliance & Quality Assurance
Ensure compliance with:
ICH-GCP Guidelines
ICON SOPs and Work Practices (WPs)
Local and Global Regulatory Requirements
Ethics Committee (EC) Requirements
Institutional Review Board (IRB) Requirements
Competent Authority (CA) Regulations
Maintain high-quality standards across all consent documentation.
Ensure audit and inspection readiness of consent-related processes.
Stakeholder Collaboration
Act as a primary point of contact for:
Sponsors
Study Start-Up (SSU) Project Managers
Clinical Trial Managers
Regulatory Teams
Functional Leads
Collaborate with cross-functional teams to ensure timely approval and implementation of informed consent documents.
Provide expert guidance on informed consent requirements and best practices.
Ethics & Regulatory Query Management
Review, negotiate, and resolve:
Ethics Committee (EC) Queries
Institutional Review Board (IRB) Queries
Competent Authority (CA) Questions
Support submission and approval processes for country-specific and site-specific ICFs.
Ensure timely responses to regulatory feedback and document revisions.
Timeline & Risk Management
Forecast and track SIS and ICF approval timelines.
Monitor study startup milestones related to consent documentation.
Identify potential risks impacting approvals and implement mitigation strategies.
Escalate critical issues when necessary.
Subject Matter Expertise (SME)
Serve as a Subject Matter Expert for informed consent processes and regulations.
Monitor changes in:
Global informed consent requirements
Country-specific regulations
Ethical guidelines
Language and translation requirements
Provide recommendations and guidance based on evolving regulatory landscapes.
Training & Knowledge Sharing
Develop and deliver training programs related to informed consent processes.
Support onboarding and mentoring of new team members.
Share best practices and lessons learned across the organization.
Documentation & Trial Master File (TMF) Management
Ensure completeness, accuracy, and quality of informed consent documents.
Verify proper filing and archival of documentation within the Trial Master File (TMF).
Maintain inspection-ready documentation throughout study execution.
Audit & Inspection Support
Represent the Functional Service Area (FSA) during:
Internal Audits
Sponsor Audits
Regulatory Inspections
Participate in departmental committees, working groups, and process improvement initiatives.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Pharmacy
Biotechnology
Nursing
Medical Sciences
Healthcare or Related Scientific Discipline
Required Experience
Industry Experience
4 to 8 years of experience in:
Clinical Trial Feasibility
Study Start-Up (SSU)
Site Activation Activities
Mandatory Experience
Minimum 2 years of hands-on experience in ICF Writing, Development, or Review.
Experience managing informed consent documentation across clinical studies.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
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Washington |Delaware :
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Berlin |Baden-Wurttemberg :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Mississauga | Uxbridge | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
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Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Sofia |Sweden :
Sweden |Taipei :
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Warsaw |
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