Job Title: Site Specialist I
Location: Chennai, Bangalore, India (Office With Flexibility)
Company: ICON plc
Employment Type: Full-time
Salary: ₹8 LPA – ₹13 LPA (Estimated)
Job Description
ICON plc is seeking a Site Specialist I to support clinical trial site activation and operational processes. In this role, you will assist with vendor coordination, documentation management, and site activation activities to ensure successful project delivery.
You will collaborate with cross-functional teams and clinical research stakeholders to ensure timely site activation, accurate documentation, and regulatory compliance across multiple clinical studies.
Key Responsibilities
Coordinate vendor access and activation activities, working with external vendors such as eCRF and IVRS providers.
Manage clinical development plan (CDP) and submission documentation, ensuring accuracy and compliance.
Maintain and update study trackers to monitor project milestones and progress.
Collaborate with Site Partners, CRAs, IHCRAs, and CTAs to optimize study performance and support site activation.
Assist in forecasting and tracking site activation plans within internal systems.
Participate in study review meetings to support risk identification and mitigation strategies.
Ensure Trial Master File (TMF) completeness and quality through timely document submission and quality checks.
Follow ICH-GCP guidelines, regulatory standards, and internal SOPs to maintain compliance.
Required Qualifications
Bachelor’s degree in Life Sciences or a related discipline.
Minimum 3 years of experience in clinical research, site operations, or clinical documentation management.
Understanding of clinical trial processes and site activation workflows.
Familiarity with vendor systems such as eCRF and IVRS.
Preferred Skills
Strong organizational and documentation management skills.
Attention to detail and ability to manage multiple tasks simultaneously.
Knowledge of ICH-GCP guidelines and regulatory requirements.
Ability to collaborate effectively within cross-functional teams.
Strong communication and coordination abilities in a fast-paced clinical research environment.
Benefits
Employees at ICON plc may receive benefits such as:
Competitive salary and performance incentives
Paid annual leave and holidays
Comprehensive health insurance plans for employees and families
Retirement savings and financial planning programs
Global Employee Assistance Programme (TELUS Health) for wellbeing and mental health support
Life insurance coverage
Flexible benefits including childcare support, gym memberships, travel subsidies, and wellness programs
About the Company
ICON plc is a leading healthcare intelligence and clinical research organization partnering with pharmaceutical, biotechnology, and medical device companies to accelerate clinical development and deliver innovative treatments to patients worldwide.
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