Job Title: Clinical Research Associate (CRA I / CRA II)
Location: Mumbai, India (Office With Flex)
Job Type: Full-Time
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and treatments that improve patient outcomes worldwide. Guided by integrity, collaboration, agility, and inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality clinical research solutions across all phases of clinical development.
Position Overview
ICON is seeking an experienced Clinical Research Associate (CRA I / CRA II) to join its Clinical Operations team. In this role, you will be responsible for the successful execution of clinical trial monitoring activities, ensuring protocol compliance, data integrity, patient safety, and adherence to regulatory requirements. The ideal candidate will possess strong on-site monitoring experience and expertise in Oncology and/or Immunology clinical studies.
Key Responsibilities
Conduct site qualification, site initiation, routine monitoring, and close-out visits in accordance with study protocols and regulatory requirements.
Ensure investigator sites remain compliant with study protocols, ICH-GCP guidelines, sponsor requirements, and applicable regulatory standards.
Monitor patient safety, informed consent processes, source documentation, and investigational product accountability.
Perform source data verification (SDV) and source data review (SDR) to ensure data accuracy, completeness, and integrity.
Identify, document, and resolve protocol deviations, study issues, and site-related challenges.
Collaborate closely with investigators, site coordinators, and study personnel to facilitate efficient study conduct.
Review clinical trial data and support timely query resolution to maintain high-quality study databases.
Prepare comprehensive monitoring visit reports and maintain essential study documentation.
Contribute to the preparation, review, and maintenance of clinical trial documents, including protocols, monitoring plans, and clinical study reports.
Support inspection readiness activities and ensure compliance throughout the study lifecycle.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine, or another healthcare-related discipline.
Minimum 3 years of Clinical Research Associate experience with hands-on on-site monitoring responsibilities.
Demonstrated experience in conducting monitoring visits independently across multiple clinical trial phases.
Strong knowledge of clinical research methodologies, clinical trial operations, and regulatory requirements.
Thorough understanding of ICH-GCP, FDA, EMA, and applicable local regulatory guidelines.
Mandatory experience in Oncology and/or Immunology therapeutic areas.
Excellent organizational, analytical, and problem-solving skills.
Strong verbal and written communication abilities with the capability to manage site relationships effectively.
Ability to work independently while collaborating within global cross-functional teams.
Technical Skills
Site Qualification Visits (SQV)
Site Initiation Visits (SIV)
Interim Monitoring Visits (IMV)
Close-Out Visits (COV)
Source Data Verification (SDV)
Source Data Review (SDR)
Clinical Trial Management Systems (CTMS)
Electronic Data Capture (EDC) Systems
Clinical Trial Documentation Management
ICH-GCP Compliance
Risk-Based Monitoring Methodologies
Regulatory Inspection Readiness
Preferred Qualifications
Experience working within a Clinical Research Organization (CRO) environment.
Exposure to global, multi-center clinical trials.
Experience supporting Phase I–IV clinical studies.
Strong understanding of risk-based monitoring approaches.
Prior experience working with international sponsors and global study teams.
Knowledge of emerging clinical technologies and decentralized trial methodologies is advantageous.
Travel Requirements
Ability to travel up to 60% or more as required.
Willingness to travel both domestically and internationally.
Ability to manage frequent site visits and monitoring responsibilities.
Valid driver's license preferred where applicable.
Why Join ICON
Work with one of the world's leading clinical research organizations.
Contribute to innovative clinical programs that advance healthcare globally.
Collaborate with highly experienced professionals across international teams.
Access structured learning, mentorship, and career development opportunities.
Be part of a culture that values innovation, inclusion, collaboration, and professional growth.
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