Prepare for Your ICON Plc Interview with Real Experiences!
View interviews
AmbitionBox
Search
Jobs
- Reviews
- Salaries
- Interview Questions
- About Company
- Benefits
- Jobs
- Office Photos
- Community
Add office photos
Premium Employer
i
This company page is being actively managed by
ICON Plc Team. If you also belong to the team, you
can get access from
here
ICON
Plc
CompareProud winner of ABECA 2025 - AmbitionBox Employee Choice Awards
All Filters
89 ICON Plc Jobs
Informed Consent Specialist II
2-7 years
Chennai, Bangalore / Bengaluru, Thiruvananthapuram
1 vacancy
Informed Consent Specialist II
ICON Plc
posted 1 week ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Informed Consent Specialist II - Office or Home - India
Were currently seeking an Informed Consent Form (ICF) Specialist to join our diverse and dynamic team. As an ICF Specialist at ICON, youll 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 youll 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:
- Minimum 2 years of experience in ICF writing/development.
- Strong English writing and 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
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here .
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Employment Type: Full Time, Permanent
Read full job description
What people at ICON Plc are saying
What ICON Plc employees are saying about work life
based on 858 employees
Flexible timing
Monday to Friday
No travel
Day Shift
ICON Plc Benefits
Submitted by Company
Meaningful Work Rewards & Benefits Career Advancement Vibrant Culture
Submitted by Employees
View more benefits 
Compare ICON Plc with
IQVIA
Compare
Syngene International
Compare
SGS
Compare
Aragen Life Sciences
Compare
SAI Life Sciences
Compare
Parexel International
Compare
Fortrea Development India Private Limited
Compare
Qinecsa Solutions
Compare
Syneos Health
Compare
Reliance Life Sciences
Compare
Lambda Therapeutic Research
Compare
Aizant Drug Research Solutions
Compare
Veeda Clinical Research
Compare
Equinox Labs
Compare
Cliantha Research
Compare
MRO
Compare
Navitas Life Sciences
Compare
Fortis Memorial Research Institute
Compare
Perceptive
Compare
National Environmental Engineering Research Institute
Compare
Similar Jobs for you
ICON Plc Chennai Office Location
Chennai Office
CHENNAI ONE IT PARK (SEZ)
4th Floor, Phase II, North Block – B
Pallavaram - Thoraipakkam - 200ft Road
Thoraipakkam, Chennai - 600097
TamilNadu, India
Chennai
600097
600097
Informed Consent Specialist II
2-7 Yrs
Chennai, Bangalore / Bengaluru, Thiruvananthapuram
Virtual Assistant, Quality Assurance, Healthcare +6 more
Contract Analyst I
6-8 Yrs
Chennai, Bangalore / Bengaluru
Quality Assurance, Computer Networking, Healthcare +4 more
Site Specialist II
3-7 Yrs
Chennai, Bangalore / Bengaluru
Quality Assurance, Healthcare, Clinical Research +6 more
Contract Analyst I
6-10 Yrs
Chennai, Bangalore / Bengaluru
Quality Assurance, Computer Networking, Healthcare +4 more
Site Specialist II
3-6 Yrs
Chennai, Bangalore / Bengaluru
Quality Assurance, Healthcare, Clinical Research +6 more
Senior Investigator Payment Coordinator
4-5 Yrs
Chennai
Quality Assurance, Hospital Administration, Healthcare +6 more
Senior Investigator Payment Coordinator
4-5 Yrs
Chennai
Quality Assurance, Hospital Administration, Healthcare +6 more
Director, IT
6-11 Yrs
Chennai
Computer Operating, Software Configuration Management, Computer Networking +12 more
Accounts Payable Associate
1-4 Yrs
Chennai
Finance, Excel, Accounting +13 more
Imaging Support Specialist
1-4 Yrs
Chennai
Computer Networking, Non Voice Process, CCNA +11 more
Share an Interview