Job Title: Informed Consent Specialist (ICF Specialist)
Location: Bangalore, Chennai, Trivandrum, India (Office With Flex)
Job Type: Full-Time
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and treatments that improve patient outcomes worldwide. Guided by integrity, collaboration, agility, and inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality clinical research solutions across all phases of clinical development.
Position Overview
ICON is seeking an experienced Informed Consent Specialist (ICF Specialist) to join its Site Start-Up and Site Activation team. In this role, you will be responsible for the development, review, approval, and management of Subject Information Sheets (SIS) and Informed Consent Forms (ICFs) across global clinical trials. You will work closely with sponsors, project teams, regulatory stakeholders, and ethics committees to ensure informed consent documentation meets regulatory requirements, ethical standards, and study timelines.
This position is ideal for professionals with strong experience in Site Activation, Study Start-Up, and Informed Consent Form development who are passionate about ensuring ethical and compliant clinical research practices.
Key Responsibilities
Develop, review, edit, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICFs) for global, country-specific, and site-specific clinical trial requirements.
Ensure informed consent documentation complies with ICON SOPs, work practices, ICH-GCP guidelines, sponsor requirements, and applicable country regulations.
Serve as a primary point of contact for Sponsors, Site Start-Up (SSU) teams, Clinical Trial Managers (CTMs), and Project Managers regarding ICF-related activities.
Review, negotiate, and resolve Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) comments, requests, and queries related to informed consent documents.
Manage ICF approval timelines and proactively identify, communicate, and mitigate potential risks impacting study start-up activities.
Maintain awareness of evolving regulatory requirements, language standards, and informed consent guidance across global regions.
Act as a Subject Matter Expert (SME) for informed consent processes and provide consultation to internal stakeholders.
Develop and deliver training sessions related to informed consent requirements, documentation standards, and regulatory updates.
Ensure complete, accurate, and compliant filing of informed consent documentation within the Trial Master File (TMF).
Support inspection readiness activities and participate in audits, inspections, governance committees, and departmental initiatives.
Mentor and coach new team members during onboarding and ongoing professional development.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Clinical Research, Healthcare, or a related discipline.
4–8 years of experience in Clinical Research, Site Start-Up, Feasibility, or Site Activation functions.
Minimum 2 years of direct experience in Informed Consent Form (ICF) writing, development, review, and approval.
Strong understanding of informed consent regulations and ethical requirements governing clinical trials.
Thorough knowledge of ICH-GCP guidelines and applicable local and global regulatory requirements.
Excellent English writing, editing, and communication skills.
Strong attention to detail and document quality management skills.
Ability to manage multiple priorities and deadlines in a fast-paced environment.
Technical Skills
Informed Consent Form (ICF) Development
Subject Information Sheet (SIS) Writing
Ethics Committee (EC) Submissions
Institutional Review Board (IRB) Query Management
Competent Authority (CA) Communications
Site Activation & Start-Up Processes
Trial Master File (TMF) Documentation
Regulatory Compliance
Clinical Trial Documentation Management
Risk Assessment & Mitigation
Clinical Protocol Review
Stakeholder Management
Preferred Qualifications
Experience supporting global and multi-country clinical trials.
Protocol interpretation and protocol review experience.
Knowledge of country-specific informed consent requirements.
Previous experience serving as a Subject Matter Expert (SME).
Experience supporting regulatory inspections and sponsor audits.
Exposure to process improvement and quality management initiatives.
Leadership & Collaboration
Collaborate with Sponsors, Clinical Trial Managers, Project Managers, Regulatory Teams, and Site Activation teams.
Provide mentorship and onboarding support to new hires.
Serve as an internal expert for informed consent processes and regulatory compliance.
Contribute to departmental process enhancements and operational excellence initiatives.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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 :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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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 :
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Lisbon | Oeiras | Portugal |WI :
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Tuscaloosa |D.C :
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Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
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Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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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 :
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Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
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 :
Renfrew | Uxbridge | Mississauga | North York | Australia | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Barcelona |Madrid :
Madrid |Cebu Province :
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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 :
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Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Tel Aviv | Kfar Saba | Yavne | Netanya | Be'Er Sheva |Remote :
Milwaukee | Tulsa | Bishop | Remote - Africa | Texas | Lousiana | Perth | Medan | Slovakia | Victoria | Regulatory Labeling Manager (NA and LATAM Only) | Hammond | Switzerland | Remote - Europe | Castlebar | Zaragoza | Green Way | Thailand | Melbourne | French | Springville | Bountiful | Ireland | Riga | Remote - Middle East | Leinster | Xzagreb | McFarland | Blue Bell | Faridabad | Hungary | Remote - South America (Latin Americal) | Belgium | Nairobi | Minnesota | Manipal | Lenexa |Republic of Colombia :
Bogota |Williamson :
Brentwood |Bucharest :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Najran | Khulais | Riyadh | Rabigh | King Abdullah Economic City | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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