Clinical Research Job at IQVIA
Searching for a rewarding Clinical Research Job in India with global exposure and hybrid work flexibility? Here is an exciting opportunity from IQVIA Careers for the role of SSU CRA in Thane. This role is ideal for candidates aiming to build a successful Life Science Career in clinical trials, monitoring, and site management. With hands-on experience in GCP guidelines, clinical operations, and regulatory compliance, this position offers a strong opportunity for life science graduates to work with one of the world’s leading clinical research organizations.
About the Company – IQVIA
IQVIA is a world-leading clinical research, healthcare analytics, and commercial solutions company that supports the life sciences industry with advanced technology and data-driven solutions. Known for innovation in clinical trials and healthcare intelligence, IQVIA Careers provide professionals with opportunities to work on global research projects, pharmaceutical development, and patient-centered healthcare solutions. The company is recognized worldwide for building strong Life Science Career pathways and offering outstanding opportunity for life science graduates in clinical research and healthcare sectors.
Job Details
- Job Title: SSU Clinical Research Associate (CRA)
- Location: Thane
- Employment Type: Full-Time
- Work Mode: Hybrid
- Job ID: R1541674
Role Overview
The SSU Clinical Research Associate (CRA) is responsible for conducting site monitoring and site management activities to ensure clinical studies are performed in accordance with study protocols, regulatory requirements, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and sponsor expectations.
The role involves close collaboration with clinical trial sites, study teams, and stakeholders to ensure high-quality data collection, regulatory compliance, and efficient study execution.
Key Responsibilities
Site Monitoring & Study Management
- Conduct site selection, initiation, routine monitoring, and close-out visits
- Ensure study conduct complies with protocol requirements, GCP, ICH guidelines, and applicable regulations
- Evaluate site performance and ensure adherence to quality and compliance standards
- Escalate quality or compliance concerns when necessary
Patient Recruitment & Site Support
- Collaborate with sites to implement and track subject recruitment plans
- Support enrollment activities to improve recruitment predictability and study timelines
- Provide protocol and study-related training to assigned sites
Documentation & Regulatory Compliance
- Track regulatory submissions, approvals, recruitment status, and data query resolution
- Ensure site documents are complete and maintained appropriately within the Trial Master File (TMF) and Investigator Site File (ISF)
- Prepare monitoring visit reports, follow-up letters, and required study documentation
Cross-Functional Collaboration
- Coordinate with study teams and stakeholders to support smooth project execution
- Assist in study start-up activities where applicable
- Support site financial management and invoice retrieval processes when required
Educational Qualification
- Bachelor’s degree in a scientific discipline or healthcare-related field preferred
Experience
- Minimum 1 year of on-site clinical monitoring experience required
- Equivalent combinations of education, training, and experience may also be considered
Required Skills & Competencies
- Strong knowledge of GCP, ICH guidelines, and clinical research regulatory requirements
- Understanding of therapeutic areas and study protocols
- Proficiency in Microsoft Word, Excel, PowerPoint, and digital devices such as laptops, iPhones, and iPads
- Strong written and verbal communication skills in English
- Effective organizational, problem-solving, and time management skills
- Ability to manage financial and operational responsibilities efficiently
- Strong interpersonal skills with the ability to build relationships with sites, clients, managers, and team members
Role Impact
The SSU CRA plays a vital role in maintaining study quality, participant safety, and regulatory compliance by ensuring accurate monitoring, effective site management, and successful execution of clinical trials.
