Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, medical device, and public health organizations in advancing clinical development and improving patient outcomes.
Job Details
|
Category |
Details |
|---|---|
|
Job Title |
Informed Consent Form (ICF) Specialist |
|
Company |
ICON plc |
|
Locations |
Bangalore / Chennai |
|
Work Mode |
Office with Flex |
|
Department |
Feasibility / Site Start-Up / Site Activation |
|
Industry |
Clinical Research / Pharmaceutical / Biotechnology |
|
Employment Type |
Full-Time |
|
Experience Required |
4–8 Years |
|
Mandatory Experience |
Minimum 2 years in ICF Writing/Development |
Role Summary
The Informed Consent Form (ICF) Specialist is responsible for developing, reviewing, and managing informed consent documentation for clinical trials. The role ensures that Subject Information Sheets (SIS) and Informed Consent Forms (ICFs) comply with regulatory requirements, ethical standards, and sponsor expectations across global, country-specific, and site-specific studies.
The position also involves stakeholder coordination, regulatory query management, timeline tracking, training support, and maintaining accurate Trial Master File (TMF) documentation.
Key Responsibilities
1. ICF Development & Review
Prepare, review, and approve:
Subject Information Sheets (SIS)
Informed Consent Forms (ICF)
Support:
Global master templates
Country-specific versions
Site-specific adaptations
Ensure document accuracy and consistency.
2. Regulatory Compliance
Apply knowledge of:
ICON SOPs/WPs
ICH-GCP guidelines
Country-specific informed consent regulations
Ensure all ICF documentation meets ethical and regulatory standards.
3. Stakeholder Collaboration
Act as a key contact for:
Sponsors
SSU Project Managers
Clinical Trial Managers
Functional leads
Collaborate with cross-functional teams to ensure timely project delivery.
4. Regulatory Query Management
Review, negotiate, and approve queries from:
Ethics Committees (EC)
Institutional Review Boards (IRB)
Competent Authorities (CA)
Address country and site-specific ICF concerns efficiently.
5. Timeline & Risk Management
Forecast and monitor:
SIS approval timelines
ICF approval timelines
Identify risks proactively and implement mitigation plans.
6. Subject Matter Expertise & Training
Serve as a Subject Matter Expert (SME) on assigned ICF-related topics.
Stay updated on:
Regulatory changes
Language requirements
Informed consent standards
Develop and conduct training sessions.
7. Documentation & TMF Management
Ensure accurate and complete transfer of ICF documents into:
Trial Master File (TMF)
Maintain audit-ready documentation standards.
8. Mentorship & Representation
Mentor and support onboarding of new hires.
Represent the department during:
Audits
Inspections
Committees
Work groups
Required Qualifications
Experience Requirements
4–8 years of experience in:
Feasibility
Study Start-Up
Site Activation
Mandatory:
Minimum 2 years in ICF writing/development
Regulatory & Functional Knowledge
Strong understanding of:
ICH-GCP guidelines
Informed consent regulations
Clinical trial start-up processes
Ethical review processes
Technical & Functional Skills
Expertise Areas
ICF development and customization
SIS preparation
Regulatory submissions
TMF documentation
Regulatory query handling
Site activation workflows
Preferred Knowledge
Protocol interpretation and review (preferred)
Soft Skills
Strong English writing skills
Excellent verbal communication
Analytical and problem-solving abilities
Attention to detail
Stakeholder management
Team collaboration skills
Organizational and multitasking abilities
Preferred Candidate Profile
Ideal candidates may have experience in:
Informed Consent Documentation
Clinical Trial Start-Up
Site Activation
Regulatory Documentation
Ethics Committee Submissions
IRB Coordination
TMF Management
Clinical Operations
Feasibility Studies
CRO environments
Pharmaceutical or Biotechnology industries
Benefits Offered
Compensation & Rewards
Competitive salary package
Recognition and performance programs
Health & Wellbeing
Comprehensive health insurance options
Employee Assistance Programme (TELUS Health)
Life assurance coverage
Wellness initiatives
Work-Life Balance
Annual leave entitlements
Flexible employee benefits
Office with Flex working model
Family-focused support policies
Financial & Lifestyle Benefits
Retirement planning programs
Childcare vouchers
Bike purchase schemes
Discounted gym memberships
Subsidized travel passes
Health assessments
Diversity & Inclusion
ICON plc is committed to maintaining an inclusive and accessible workplace and provides equal employment opportunities regardless of:
Race
Religion
Gender
Sexual orientation
Gender identity
National origin
Disability
Veteran status
Reasonable accommodations are available during the recruitment and employment process.
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Delhi | India | New Delhi | PAN-India |Assam :
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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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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 | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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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 :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
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 :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
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 :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
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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 :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
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 :
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 :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
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 :
Richmond Hill | North York | Australia | Renfrew | Uxbridge | Mississauga |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 :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |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 :
Netanya | Be'Er Sheva | Kfar Saba | Tel Aviv | Yavne |Remote :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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