ICON Hiring Clinical Research Associate I & II (CRA)
Are you seeking ICON Careers India or a Clinical Trial Monitor Job in Mumbai? Global leader in clinical development and healthcare intelligence ICON plc has announced openings for Clinical Research Associate I/II (CRA I/II) (Job ID: JR135624).
This clinical operations monitoring vacancy is ideal for life sciences, nursing, or pharmacy graduates with a minimum of 3 years of independent on-site clinical monitoring experience. Selected candidates must possess experience monitoring therapeutic programs in oncology, immunology, gastroenterology, or pulmonology. The role requires traveling up to 60% of the time. To write a resume detailing your SDV percentage, protocol verification, or audit preparation milestones, read our guidelines on how to apply for healthcare and pharma jobs online.
📋 Job Details
| Particular | Details |
|---|---|
| Company | ICON plc (ICON India) |
| Position | Clinical Research Associate I / II (CRA I/II) |
| Job Requisition ID | JR135624 |
| Job Location | Mumbai, Maharashtra, India |
| Employment Type | Full-Time |
| Experience Required | 3+ Years (independent on-site monitoring) |
| Therapeutic Area | Oncology, Immunology, Gastroenterology, or Pulmonology (Mandatory) |
| Qualifications | Bachelor's or Master’s degree in a scientific or healthcare-related field (B.Pharm, M.Pharm, B.Sc, M.Sc) |
| Travel Requirement | At least 60% (domestic and international) |
💼 Key Responsibilities
- Site Visitation: Conduct clinical site qualification, initiation, routine monitoring, and close-out visits.
- GCP Compliance: Ensure clinical trials adhere strictly to study protocols, local regulations, and ICH-GCP guidelines.
- Source Data Audit: Perform source document verification (SDV) and case report form (eCRF) audits to ensure data integrity.
- Investigator Collaboration: Work closely with principal investigators and coordinators to optimize site recruitment and training.
- Documentation Maintenance: Oversee on-site regulatory binders and ensure synchronization with electronic trial records (eTMF).
- Safety Coordination: Verify correct reporting, categorization, and tracking of serious adverse events (SAEs).
To learn how oncology monitoring and CRA II salaries compare to conventional pharmacovigilance drug safety associate and clinical data analytics structures, read our report on Pharmacovigilance Salary: India vs USA.
🎓 Required Qualifications & Skills
- Education: Bachelor's or Master’s degree in Pharmacy, general Sciences, Nursing, or related allied health disciplines.
- Monitoring Experience: At least 3 years of active on-site clinical monitoring experience within a CRO or pharma sponsor.
- Specialty Focus: In-depth monitoring experience in oncology, immunology, gastroenterology, or pulmonology.
- Regulatory Knowledge: Thorough understanding of clinical trial processes, local drug authority regulations, and ICH-GCP.
- License Requirement: Must hold a valid driver's license and be prepared to travel extensively (up to 60%).
For science graduates evaluating corporate monitoring pathways compared to conventional laboratory quality control or chemical dispensing chemist careers, read our analysis on B.Pharm Careers after Graduation: India vs USA.
🎁 Why Join ICON plc?
- Work inside one of the largest and most respected global contract research organizations (CROs).
- Advance your technical career by managing complex clinical protocols in oncology and specialty medicine.
- Comprehensive health and wellbeing programs, including medical and life assurance plans.
- Access to global employee support networks (TELUS Health) and structural training academies.
To review your basic knowledge of clinical databases, safety protocols, and GCP guidelines before your technical screenings, try our interactive Clinical Trial Assistant (CTA) Quiz.
💡 CRA vs Healthcare IT
Clinical Research Associates conduct site monitoring visits, verify protocol compliance, and audit source documentation, whereas Healthcare IT professionals support software deployments. To explore these differences, read our comparison on Healthcare IT vs Clinical Healthcare.
📝 Resume Tips for ICON CRA Candidates
- Quantify Specialty Studies: Detail the number of oncology or immunology sites you have monitored.
- State Regulatory Audits: Mention if you have guided sites through FDA, EMA, or national regulatory inspections.
- Detail eClinical Systems: Name the specific clinical trial databases (e.g. Oracle Clinical, Rave, Medidata) you are proficient in using.
💬 ICON CRA I/II Interview Questions
- Q1. What are the key elements to verify during a Site Initiation Visit (SIV)?
Answer Guidance: I verify that investigator site files are complete, study materials and IP have arrived, site personnel are trained on protocols and electronic systems, and investigator delegations are signed. - Q2. How do you manage a site that is persistently late in resolving data queries?
Answer Guidance: I discuss the backlog with the coordinator to identify resource bottlenecks, provide retraining if there is a technical gap, establish a query resolution timeline, and escalate to the Lead CRA if delays continue. - Q3. Explain the regulatory significance of checking investigator site file (ISF) drug logs.
Answer Guidance: Reviewing drug logs ensures the investigational product (IP) was stored at protocol temperature, dispensed only to eligible subjects, and that used/unused counts reconcile, verifying trial compliance.
🚀 How to Apply?
Interested and eligible candidates can submit their applications directly via ICON's official Workday careers board. Click the button below to apply:
Apply Online – ICON Workday Career Board❓ Frequently Asked Questions
Q. Do I need experience in oncology clinical trials to apply?
Yes, ICON requires candidates to have mandatory monitoring experience in oncology, immunology, gastroenterology, or pulmonology.
Q. What is the travel requirement for the CRA I/II position?
The position involves active field monitoring, requiring domestic and international travel at least 60% of the time.
Q. Is a driver's license mandatory for this position?
Yes, a valid driver's license is required as the role involves driving to different clinical trial sites.
.png)
