Apply for the Parexel Hiring for iCRA II Clinical Research in Bengaluru. Manage site start-up, submissions, TMF quality, and clinical trial compliance.
Parexel, a globally respected Clinical Research Organization, is hiring for the position of iCRA II at its Bengaluru location. This role forms a crucial part of Parexel’s clinical operations team and offers the opportunity to contribute directly to clinical trial execution, regulatory processes, and site management. Parexel continues to lead the global clinical research industry by partnering with pharmaceutical, biotechnology, and medical device companies to improve patient health worldwide. Parexel Hiring for iCRA II Clinical Research
The iCRA II role is designed for experienced clinical research professionals who possess strong understanding of clinical trial methodology, site activation processes, regulatory submissions, and ongoing operations from study start-up to close-out. It is a dynamic position that requires strong coordination, technical knowledge, communication abilities, and the capacity to operate independently with limited oversight. Parexel Hiring for iCRA II Clinical Research
This long-format post explains job responsibilities, skills, qualifications, key expectations, and step-by-step details on how to apply.
About Parexel
Parexel firmly believes that when values align, exceptional results follow. The organization is committed to improving global health through ethical, high-quality clinical research and development practices. Every member of the Parexel team, regardless of role or responsibility, contributes to therapies that benefit patients across the world. The company focuses heavily on quality, clinical excellence, scientific integrity, and patient-centered approaches. Parexel Hiring for iCRA II Clinical Research
Employees are encouraged to take personal ownership of their work and to deliver solutions with empathy and purpose. Parexel cultivates an environment that supports learning, collaboration, professional development, and innovation. Parexel Hiring for iCRA II Clinical Research
Job Title and Details
Position: iCRA II (Intermediate Clinical Research Associate Level II)
Location: Bengaluru, India
Job Posting: Today
Requisition ID: R0000036655
Work Type: Full-Time
The role emphasizes responsibility from site identification to site close-out, ensuring that clinical trial activities meet regulatory, sponsor, and organizational requirements. The iCRA II supports multiple phases of a clinical study and plays a vital role in advancing a project from concept to completion. Parexel Hiring for iCRA II Clinical Research
Key Accountabilities and Responsibilities
The responsibilities of the iCRA II cover the full lifecycle of clinical trial operations. Parexel Hiring for iCRA II Clinical Research
1. Start-Up Phase (Site Identification to Activation)
The start-up phase is critical to the success of a clinical trial. As an iCRA II, you will:
Serve as a Direct Point of Contact
- Act as Parexel’s primary contact for assigned clinical sites.
- Build strong professional relationships with investigators, coordinators, and site staff.
- Ensure quality, efficiency, and adherence to timelines during start-up.
Conduct Site Feasibility and Qualification
- Support country-specific feasibility studies.
- Participate in pre-qualification and qualification activities for new sites.
- Conduct remote Qualification Visits (QVs) if required.
Manage Confidentiality and Regulatory Documentation
- Prepare and negotiate Confidentiality Agreements (CDA).
- Handle amendments and ensure proper execution.
- Ensure all documents meet First Time Quality standards.
Develop Document Strategy
- Configure, distribute, collect, and review essential regulatory documents.
- Ensure country-specific and site-specific documents are accurate and compliant.
- Prepare high-quality Site Initiation Visit (SIV) readiness documents.
Informed Consent Form (ICF) Preparation
- Customize and review country-specific ICFs.
- Ensure translations meet regulatory, client, and ethics committee requirements.
- Negotiate amendments when required.
IRB/IEC and Regulatory Submissions
- Prepare, submit, and follow up on submissions to IEC/IRB and regulatory authorities.
- Resolve conflicts and ensure approval timelines are met.
- Maintain proper documentation in the Trial Master File (TMF).
Site Activation Strategy
- Build strategies for approval timelines, site activation, and document collection.
- Update the Clinical Trial Management System (CTMS) promptly.
Problem-Solving and Issue Resolution
- Identify risks related to site initiation, recruitment, or compliance.
- Provide solutions or escalate when necessary.
- Support sites in resolving system access or training-related issues.
2. Maintenance Phase (Initiation to Close-Out)
During ongoing trial execution, your responsibilities include: Parexel Hiring for iCRA II Clinical Research
- Customizing and negotiating ICF amendments.
- Managing submissions and follow-ups for ethics committees and regulators.
- Ensuring TMF documents are filed accurately as per guidelines.
- Ensuring all site and study documents remain inspection-ready.
3. Full Lifecycle Accountability
The role requires consistent oversight from start-up to close-out:
- Ensure timely completion of project milestones.
- Maintain CTMS and eTMF data accuracy.
- Ensure sites implement high-quality, compliant processes.
- Support team members to meet project goals.
- Build relationships that facilitate smooth project execution.
- Conduct regular reviews of data accuracy, documents, and compliance.
4. Compliance and Quality Management
You must ensure: Parexel Hiring for iCRA II Clinical Research
- Compliance with ICH-GCP guidelines at all times.
- Adherence to local and international regulations.
- Compliance with Parexel SOPs and sponsor-specific requirements.
- Sites remain audit- and inspection-ready throughout the study.
- High-quality, consistent work output and documentation integrity.
5. Team Collaboration and Professional Development
- Work collaboratively in a matrix environment.
- Participate in team discussions and provide feedback.
- Mentor junior team members when needed.
- Assist in team alignment toward project milestones.
- Contribute to performance development reviews.
Required Skills and Competencies
Parexel expects applicants to demonstrate exceptional professional and technical skills: Parexel Hiring for iCRA II Clinical Research
Technical Competencies
- Strong knowledge of CTMS, eTMF, and clinical systems.
- Understanding of clinical trial methodology.
- Ability to manage regulatory submissions and TMF quality.
- Experience with documentation management and ICF customization.
Communication Skills
- Excellent verbal and written communication abilities.
- Strong presentation skills (meetings, trainings, sponsor calls).
- Ability to interact professionally with clients and internal leaders.
Analytical and Operational Skills
- Skilled in identifying potential risks and providing solutions.
- Strong prioritization and time management capabilities.
- Ability to make decisions independently in ambiguous scenarios.
- Ability to handle multiple tasks with high accuracy.
Soft Skills
- Sense of urgency in completing tasks.
- Positive attitude and willingness to learn new methods.
- Team-oriented mindset with cross-cultural adaptability.
- Attention to detail and commitment to work quality.
- Ability to work independently with minimal supervision.
Knowledge and Experience Requirements
Candidates must have: Parexel Hiring for iCRA II Clinical Research
- Strong experience in study start-up activities.
- Equivalent experience in clinical research operations.
- Sound understanding of clinical research terminology.
- Hands-on experience managing documentation, submissions, and site-level activities.
Educational Qualifications
- Degree in Biological Sciences, Pharmacy, Nursing, or other health-related discipline.
- Equivalent clinical qualifications or relevant experience may also be considered.
Parexel Hiring for iCRA II Clinical Research
Why Join Parexel?
- Opportunity to work on global, high-impact clinical trials.
- Exposure to diverse therapeutic areas and regulatory environments.
- Strong professional growth and learning opportunities.
- Supportive team culture with ethical work practices.
- Competitive compensation and long-term career development pathways.
How to Apply
To apply for the iCRA II position at Parexel:
- Visit the official Parexel Careers website.
- Search for Requisition ID: R0000036655.
- Open the iCRA II job listing for the Bengaluru location.
- Fill in required personal details and upload your updated resume.
- Submit your application and check for email updates from the hiring team.
Early applications are encouraged since roles may close once enough candidates are shortlisted. Parexel Hiring for iCRA II Clinical Research
For verified pharma job updates, visit PharmaJobHub.in – India’s trusted pharma career portal.
Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
