ICON is the world’s largest and most comprehensive clinical research organization, renowned for leveraging cutting-edge science to transform lives. With over two decades of partnership with leading pharmaceutical companies, ICON has made a significant impact in therapeutic areas such as cancer, cardio-metabolic diseases, vaccines, and oncology. If you’re looking to contribute to healthcare innovation, this role in Mumbai could be your ideal career destination.
About the Role: Clinical Research Associate II (CRA II)
This remote role, based in Mumbai, offers the opportunity to collaborate with a global pharmaceutical leader. While primarily remote, the position requires flexibility to visit the client office as needed. You will play a pivotal role in ensuring the success of clinical trials by monitoring site activities, maintaining high-quality data, and adhering to international guidelines.
Responsibilities in the Job
As a Clinical Research Associate II, your key responsibilities will include:
- Site Management
- Oversee all aspects of study site management, from selection and initiation to routine monitoring and close-out visits.
- Data Quality Assurance
- Ensure high-quality data collection with low query levels.
- Maintain compliance with Quality Assurance standards.
- Client Collaboration
- Work closely with the client’s study team while supported by a dedicated ICON line manager.
- Regulatory Compliance
- Adhere to international guidelines such as ICH-GCP and local regulations throughout the clinical trial process.
Qualifications Required
To excel in this role, you should possess:
- A degree in Pharmacy or a related field.
- At least 2 years of monitoring experience with global trials in a CRO or pharmaceutical company.
- Strong knowledge of ICH-GCP and local regulatory requirements.
- Excellent written and verbal communication skills.
- Flexibility to travel and work on-site as needed.
Skills and Attributes for Success
- Attention to Detail: Ensure precise data collection and compliance with guidelines.
- Team Collaboration: Work effectively with both ICON and client teams.
- Adaptability: Be ready to switch between remote and on-site responsibilities.
- Communication Skills: Clearly articulate findings and collaborate across teams.
