Job Title: Core ICF Developer/Writer and Reviewer (Centralized Role)
Location: Buenos Aires
Category: Clinical
Job ID: 25858
The Core ICF Developer/Writer and Reviewer is responsible for developing, reviewing, finalizing, and maintaining clinical trial documents, primarily Informed Consent Forms (ICFs), ensuring compliance with regulatory requirements, GCP guidelines, and client-specific standards. This role ensures that trial participants fully understand study-related information and that documents align with protocol and regulatory standards.
Document Development & Review
Develop, review, finalize, and maintain clinical trial documents such as Informed Consent Forms (ICFs).
Ensure Master ICF content is consistent with the corresponding protocol and clearly informs subjects about all necessary study information.
Simplify scientific and medical language for research participants to ensure understanding.
Ensure documents comply with global industry standards and client-specific guidance.
Support development, review, and approval of master templates for efficient protocol/site activation.
Stakeholder Communication
Timely and appropriate communication with all relevant stakeholders.
Liaise with Project Managers/Designees to report trends, outstanding issues, safety concerns, or potential risks impacting trial delivery or patient safety.
Influence stakeholders through insight into industry trends and document standards.
Training & Mentorship
Create, review, and revise training materials and plans to support team requirements.
Mentor and train team members on document development and review processes.
Quality & Compliance
Deliver high-quality work consistently.
Plan, prioritize, and meet deadlines effectively.
Ensure adherence to regulatory requirements, policies, and procedures for clinical trials, including FDA, GDPR, GCP, and biological sample regulations.
Strong knowledge of drug development processes.
Understanding of FDA IND/NDA requirements.
Knowledge of regulations and guidelines: ICH-GCP, FDA regulations, GDPR, biological sample regulations.
Familiarity with medical terminology and health literacy principles (preferred).
Excellent customer service and stakeholder management skills.
Advanced computer skills, including proficiency in MS Word.
Excellent written and verbal communication in English.
Strong attention to detail and ability to deliver high-quality work in a dynamic environment.
Ability to negotiate, influence, mentor, and train others.
University/College Degree (medical degree preferred).
Minimum 5 years of experience in writing and editing master ICFs and other clinical trial-related documents.
Advanced English proficiency (oral and written).
Strong working knowledge of ICH-GCP guidelines and applicable regulations.
Candidates without a medical/life sciences degree but with relevant domain knowledge and experience may also be considered.
Fast-paced, dynamic clinical research environment.
Collaboration with cross-functional teams and stakeholders.
Gujarat :
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Siliguri |Illinois :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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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 :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |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 :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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