Clinical Research Associate I/II

Why This Role Matters

Clinical trials are the foundation of medical innovation. In high-impact therapeutic areas such as Oncology and Immunology, precision, compliance, and patient safety are critical. Every monitoring visit, every data query resolved, and every protocol deviation addressed contributes to the development of potentially life-saving therapies.
As a Clinical Research Associate (CRA) II at ICON plc, you play a direct role in ensuring that clinical trials are conducted ethically, safely, and in full compliance with regulatory standards. Your oversight ensures that complex oncology and immunology studies generate reliable data while protecting trial participants. This position is instrumental in advancing innovative treatments from development to regulatory approval.

Job Description

The Clinical Research Associate II is responsible for managing and monitoring assigned clinical trial sites in accordance with study protocols, sponsor expectations, ICH-GCP guidelines, and applicable regulatory requirements. This role requires strong on-site monitoring experience, therapeutic expertise in Oncology or Immunology, and the ability to independently manage site relationships.
The CRA II acts as the primary liaison between the sponsor and investigational sites, ensuring that studies are conducted with integrity and operational efficiency. The role involves significant travel and requires strong organizational and communication skills to manage multiple responsibilities simultaneously.

Key Features of the Role

• Focus on Oncology and Immunology therapeutic areas
• Independent on-site monitoring responsibilities
• Exposure to complex, high-impact clinical trials
• Significant travel opportunities (domestic and international)
• Cross-functional collaboration with global teams
• Career progression toward Senior CRA or Clinical Trial Manager roles
• Compliance-driven and patient-focused environment

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with monitoring plans.
• Ensure adherence to study protocols, ICH-GCP standards, and regulatory requirements.
• Review source documents to verify data accuracy and completeness.
• Ensure informed consent processes are conducted properly and documented accurately.
• Monitor patient recruitment, enrollment progress, and retention metrics.
• Identify protocol deviations, documentation gaps, and compliance risks.
• Ensure timely and accurate reporting of adverse events and safety information.
• Perform detailed data review and resolve queries in collaboration with site staff and data management teams.
• Ensure case report forms (CRFs) are complete, accurate, and submitted within required timelines.
• Collaborate with investigators and site personnel to facilitate smooth trial conduct.
• Provide training and support to site staff regarding protocol requirements and study procedures.
• Contribute to the preparation and review of essential study documentation, including protocols and clinical study reports.
• Maintain accurate monitoring visit reports and follow-up documentation.
• Manage multiple sites and ensure all milestones are met within study timelines.

Required Qualifications

• Strong understanding of clinical trial processes and lifecycle management.
• In-depth knowledge of ICH-GCP guidelines and regulatory frameworks.
• Proven experience in Oncology and/or Immunology therapeutic areas (mandatory).
• Strong analytical skills for interpreting complex clinical data.
• Excellent communication and stakeholder management abilities.
• High attention to detail and documentation accuracy.
• Ability to independently manage site activities and resolve issues proactively.

Educational Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, Biotechnology, or related healthcare discipline.
• Bachelor’s degree in Life Sciences, Pharmacy
• Advanced clinical research certifications are an added advantage.

Experience and Skills

• Minimum 3 years of experience as a Clinical Research Associate.
• Demonstrated on-site monitoring experience.
• Experience handling Oncology or Immunology clinical trials (mandatory).
• Strong administrative and documentation skills.
• Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms.
• Experience managing safety reporting and regulatory documentation.
• Ability to interpret clinical data and identify trends or discrepancies.
• Strong problem-solving and risk mitigation skills.
• Ability to work both independently and collaboratively within global teams.
• Willingness and ability to travel at least 60% (domestic and international).
• Valid driver’s license required.

Salary Insights

Compensation for the Clinical Research Associate II role is competitive and aligned with industry benchmarks for Oncology-focused CRA positions. Salary may vary based on therapeutic expertise, travel flexibility, and geographic region.

In addition to base salary, employees at ICON plc may receive:
• Comprehensive health insurance coverage
• Retirement savings programs
• Performance-linked incentives
• Annual leave entitlements
• Life assurance benefits
• Global Employee Assistance Programme (LifeWorks)
• Flexible lifestyle and wellness benefits

ICON’s total rewards framework supports career development, financial planning, and work-life balance.

Company Overview

ICON plc is a globally recognized leader in healthcare intelligence and clinical research services. The company partners with pharmaceutical, biotechnology, and medical device organizations to accelerate the development of innovative treatments across all phases of clinical development.
With a strong presence worldwide, ICON supports complex clinical programs in therapeutic areas including Oncology and Immunology. The organization fosters an inclusive, performance-driven culture focused on scientific excellence and operational quality.
Inclusion and belonging are core values at ICON. The company is committed to providing equal employment opportunities and maintaining a workplace free from discrimination and harassment.

FAQs

1. Is Oncology/Immunology experience mandatory?
Yes, therapeutic area experience in Oncology or Immunology is mandatory for this role.

2. Does this role require travel?
Yes, the position requires approximately 60% travel, including domestic and international visits.

3. Is on-site monitoring experience required?
Yes, demonstrated on-site monitoring experience is essential.

4. What growth opportunities are available?
Career progression may include Senior CRA, Lead CRA, Clinical Trial Manager, or Project Management roles.

5. Does this role involve data analysis?
The role includes data review and query resolution but does not replace formal biostatistical analysis functions.

Application Tips

• Highlight Oncology/Immunology trial experience prominently in your resume.
• Quantify monitoring experience (number of sites, visits conducted, countries supported).
• Demonstrate strong knowledge of ICH-GCP and regulatory compliance.
• Mention experience handling adverse event reporting and safety oversight.
• Emphasize travel flexibility and independent site management capability.
• Showcase examples of resolving complex site or data-related issues.