Informed Consent Specialist

Informed Consent Specialist (ICF) review and creation experience is required -
India, Bangalore / Chennai - Office with flex ICON is a global healthcare
intelligence and clinical research organisation united by a mission to bring new
medicines and treatments to patients faster. As a values-driven organisation,
integrity, collaboration, agility, and inclusion are at the heart of how we work
and interact with each other, customers, patients and suppliers. We're currently
seeking an Informed Consent Form (ICF) Specialist to join our diverse and
dynamic team. As an ICF Specialist at ICON, you'll be crucial in ensuring the
accuracy, compliance, and timely approval of informed consent forms for clinical
trials. Your role will directly contribute to the ethical conduct of clinical
research and the successful initiation of studies. What you'll be doing:
Developing and reviewing ICFs: Preparing, reviewing, and approving Subject
Information Sheets (SIS) and Informed Consent Forms (ICF) for global master
templates, country-specific versions, and site-specific adaptations. Ensuring
compliance: Applying proficient knowledge of ICON SOPs/WPs, ICH/GCP guidelines,
and applicable country regulations related to Informed Consent requirements.
Stakeholder collaboration: Serving as a key point of contact for Sponsors, SSU
Project Managers, Clinical Trial Managers, and other functional leads to
optimize performance and ensure successful project outcomes. Query resolution:
Proficiently reviewing, negotiating, and approving all Ethics Committee (EC),
Institutional Review Board (IRB), and Competent Authority (CA) queries related
to country and site-specific ICFs. Timeline management: Forecasting and tracking
SIS & ICF approval timelines, proactively identifying risks, and developing
contingency plans to mitigate potential impacts. Knowledge leadership: Acting as
a Subject Matter Expert (SME) for assigned topics, staying updated on changing
regulatory and language requirements affecting ICFs, and developing/conducting
training. Documentation and archiving: Ensuring the accuracy and completeness of
ICF documents transferred for filing into the Trial Master File (TMF).
Mentorship: Mentoring and coaching new hires during their onboarding process.
Representing FSA: Representing the department at audits, inspections, and on
various committees and work groups. Your profile: 4 to 8 years of experience in
Feasibility, Start Up and Site Activation. Must have minimum 2 years of
experience in ICF writing/development. Strong English writing and communication
skills are required. Proficient knowledge of ICH/GCP guidelines and applicable
country regulations related to Informed Consent. Ability to work collaboratively
in a team environment and effectively communicate with diverse stakeholders.
Strong analytical and problem-solving skills, with excellent attention to
detail. Protocol interpreting & review is preferred but not required. #LI-KT1
Employment with ICON is contingent upon having the legal right to work in the
country where the role is based. Rewards & Benefits ICON offers a competitive
and comprehensive total rewards package designed to support your health,
wellbeing, and career development. Benefits may include: Competitive base salary
and performance related incentives Health and wellbeing programmes including
medical, dental, and vision coverage where applicable Retirement and pension
plans Life assurance and disability coverage Employee assistance programmes and
wellbeing resources Learning and development opportunities through structured
training and career pathways Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers. Inclusion
and Accessibility ICON is an equal opportunity employer. We are committed to
building an inclusive and accessible workplace where everyone feels valued and
supported. If you require reasonable accommodations during the recruitment
process, please let us know or submit a request here. Are you a current ICON
Employee? Please click here to apply ICON is an award-winning workplace that
enables you to make a difference to patients’ lives by being part of a
world-class clinical research organisation that helps deliver new medicines &
medical devices that are benefitting patients worldwide. You are also part of a
diverse company that cares about our world and is dedicated to conducting
business more sustainably and supporting the communities in which we live. If
you’re as driven as we are, join us. You’ll be working in a great environment,
with some of the brightest and the friendliest people in the sector, and you’ll
be helping shape an industry. Didn’t find the role you were looking for? Even if
the perfect role isn’t available right now, we’re always excited to connect with
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