Clinical Research Associate II (CRA II)
Company
Fortrea – A global clinical research organization providing end-to-end clinical trial services to support the development of safe and effective medical therapies.
Job Details
Job Title: Clinical Research Associate II (CRA II)
Job Requisition ID: 262282
Employment Type: Full-time
Location: Bangalore, India
Application Deadline: June 30, 2026
Travel Requirement: ~60%
About the Role
The Clinical Research Associate II is responsible for managing and monitoring clinical trial sites in compliance with ICH-GCP guidelines, sponsor requirements, and Fortrea SOPs.
This role ensures patient safety, data integrity, and regulatory compliance across assigned clinical studies while acting as a key link between study sites and internal clinical teams.
Key Responsibilities
1. Site Management & Monitoring
Conduct clinical trial site monitoring activities including:
Pre-study visits
Site initiation visits
Routine monitoring visits
Close-out visits
Ensure compliance with:
Protocol requirements
Regulatory standards
ICH-GCP guidelines
2. Patient Safety & Compliance
Ensure proper informed consent procedures are followed.
Verify eligibility and protocol adherence for study participants.
Monitor and report protocol deviations and safety concerns.
3. Data Integrity & Source Verification
Perform:
Source data review (SDV)
eCRF review
Query generation and resolution
Ensure data accuracy, completeness, and consistency.
4. Regulatory Documentation
Ensure investigator site files and regulatory documents are:
Complete
Accurate
Up to date
Maintain oversight of eTMF and sponsor documentation.
5. Investigational Product (IP) Management
Verify proper storage and accountability of investigational products.
Track IP shipments and study supplies.
6. Reporting & Documentation
Prepare timely and accurate trip reports.
Maintain documentation in clinical trial systems (e.g., CTMS).
7. Collaboration & Communication
Work closely with study teams to meet clinical timelines.
Attend investigator meetings, team meetings, and teleconferences.
Provide training and support for site initiation and new team members.
8. Safety Reporting
Track and follow up on Serious Adverse Events (SAEs).
Ensure proper documentation and reporting of safety data.
9. Additional Responsibilities
Support recruitment and investigator documentation.
Assist in co-monitoring and training of new CRAs.
Participate in process improvement initiatives.
Required Qualifications
Education
University or college degree in:
Life Sciences
Nursing
Or related allied health field
Equivalent clinical experience may be considered
Experience
Minimum 2 years of clinical monitoring experience (CRA or equivalent role)
Skills & Knowledge
Strong understanding of:
ICH-GCP guidelines
Clinical trial processes
Regulatory requirements
Ability to perform independent site monitoring
Experience with SAE reporting and follow-up
Familiarity with eClinical systems (CTMS, EDC, etc.)
Core Competencies
Strong attention to detail
Good planning and organizational skills
Problem-solving ability
Strong communication and interpersonal skills
Ability to work independently and in a matrix environment
Ability to manage travel and site visits effectively
Preferred Qualifications
Phase I clinical trial experience
Life Sciences or Nursing background
Knowledge of Fortrea SOPs
Familiarity with medical devices (if applicable)
Experience in physiology, pharmacology, or clinical research processes
Strong analytical and negotiation skills
Exposure to audit and inspection readiness activities
Work Environment
Office and home-based work supported
Hospital and clinical site visits required
Long periods of computer use
May involve travel outside standard working hours
Inclusion & Accessibility
Fortrea is committed to equal opportunity employment and maintaining an inclusive workplace.
Reasonable accommodations are available during the recruitment process upon request.
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Remote, India | Siliguri |Illinois :
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