IQVIA Hiring – Sr. CRA1 | Clinical Research | Thane, Bengaluru, Hyderabad & Noida
IQVIA is hiring Sr. CRA1 professionals for its Clinical Research team across multiple locations in India. The role focuses on clinical trial site monitoring, site management, subject recruitment, protocol compliance, regulatory submissions, TMF and ISF documentation, and Good Clinical Practice (GCP) requirements.
Sr. CRA1 – Clinical Research
Job Details
- Company: IQVIA
- Position: Sr. CRA1
- Job ID: R1571208
- Employment Type: Full-time
- Work Mode: Hybrid
- Primary Location: Thane, India
- Additional Locations: Bengaluru, Hyderabad, Noida
Job Overview
The Sr. CRA1 will perform monitoring and site management activities to ensure that clinical trial sites conduct studies and report study data according to the study protocol, applicable regulations and guidelines, and sponsor requirements.
Key Responsibilities
Clinical Trial Site Monitoring
- Perform site monitoring visits, including:
- Site selection
- Site initiation
- Monitoring visits
- Close-out visits
- Conduct monitoring activities in accordance with the contracted scope of work and Good Clinical Practice (GCP).
- Evaluate the quality and integrity of study site practices related to proper protocol conduct.
- Ensure adherence to applicable regulations and escalate quality issues when appropriate.
Subject Recruitment & Site Management
- Work with clinical trial sites to adapt, drive and track subject recruitment plans according to project requirements.
- Support recruitment predictability and project delivery.
- Administer protocol and related study training to assigned sites.
- Establish regular communication with sites to manage project expectations and resolve ongoing issues.
Study Progress & Regulatory Activities
- Track the progress of assigned studies, including:
- Regulatory submissions and approvals
- Recruitment and enrollment
- Case Report Form (CRF) completion and submission
- Data query generation and resolution
- Support the study start-up phase when required.
TMF & ISF Documentation
- Ensure required site documents are available for filing in the Trial Master File (TMF).
- Verify that the Investigator’s Site File (ISF) is maintained according to GCP and local regulatory requirements.
- Create and maintain documentation relating to:
- Site management
- Monitoring visit findings
- Action plans
- Submit regular visit reports and generate follow-up letters and other required study documentation.
Collaboration & Project Support
- Collaborate and liaise with study team members to support project execution.
- Where applicable, support development of project-specific subject recruitment plans on a site-by-site basis.
- Where applicable, support site financial management according to executed clinical trial agreements.
- Retrieve invoices according to local requirements.
Eligibility & Qualifications
Educational Qualification
- Bachelor’s Degree in a scientific discipline or healthcare – preferred and required according to the source listing.
- An equivalent combination of education, training and experience may be accepted in lieu of a degree.
Experience
- At least 2 years of on-site monitoring experience – Required
Required Knowledge & Skills
- Good knowledge and ability to apply applicable clinical research regulatory requirements.
- Knowledge of Good Clinical Practice (GCP).
- Knowledge of International Council for Harmonisation (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided through company training.
- Proficiency in:
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Ability to use laptop computers and applicable mobile devices.
- Strong written and verbal communication skills.
- Good command of the English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Eligible Qualification Courses
The source specifies a Bachelor’s Degree in a scientific discipline or healthcare rather than specific courses. Relevant examples include:
B.Pharm | M.Pharm | Pharm.D | B.Sc. Life Sciences | M.Sc. Life Sciences | Biotechnology | Microbiology | Biochemistry | Biomedical Sciences | Other relevant Scientific or Healthcare disciplines
Location & Work Mode
Primary Location: Thane, India
Additional Locations:
Work Mode: Hybrid
Employment: Full-time
How to Apply
Interested and eligible candidates can apply through the official IQVIA careers portal.
Job Summary
| Category | Details |
|---|---|
| Company | IQVIA |
| Vacancies | Sr. CRA1 |
| Required Education | Bachelor’s Degree in Scientific Discipline or Healthcare |
| Experience | At least 2 years of on-site monitoring experience |