In-House Clinical Research Associate (CRA) at Fortrea
Position Title: In-House Clinical Research Associate (IHCRA)
Organization: Fortrea
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience Required: 2+ Years
Salary Range: ₹4.8 – ₹6 LPA
Location: Work From Home
About Fortrea
Fortrea is a prominent global contract research organization (CRO) renowned for its scientific rigor and extensive experience in clinical development. With a team of over 19,000 professionals operating across more than 90 countries, Fortrea delivers a comprehensive range of clinical development, patient access, and technology solutions across 20 therapeutic areas. The company is dedicated to transforming drug and device development for global partners and patients.
Role Overview
The In-House Clinical Research Associate (IHCRA II) plays a crucial role within a Clinical Project Team, contributing to the successful execution of clinical research projects. This position involves Clinical Operations activities that can be performed from a home-based setting, with occasional travel for site visits or team meetings as needed.
Key Responsibilities
- Clinical Data Management:
- Ensure the quality and integrity of data throughout the study.
- Perform Case Report Form (CRF) review, generate queries, and resolve them as per guidelines.
- Site Monitoring and Management:
- Serve as the primary contact for project teams and investigative sites.
- Monitor site performance and implement action plans for underperforming sites.
- Assist with site preparation, including running reports and resolving action items from previous visits.
- Regulatory Compliance:
- Oversee compliance with local regulatory and IRB/IEC requirements.
- Assist with submissions and notifications to Ethics Committees and Regulatory Authorities.
- Training and Oversight:
- Provide site training via phone or teleconference.
- Coordinate and track clinical trial supplies and ensure sites have sufficient resources.
- Project Coordination:
- Collaborate with the project team during recruitment phases and manage patient recruitment.
- Liaise with local or central laboratories and sponsor/medical monitors regarding clinical questions and study status.
Essential Qualifications
- Educational Requirements:
- University or college degree in biological or life sciences preferred, or certification in a related allied health profession (e.g., nursing licensure, medical or laboratory technology).
- Experience:
- Minimum of 2 years of relevant clinical research experience in roles such as site management, in-house CRA, study coordinator, or similar.
- Skills:
- Basic understanding of ICH-GCP guidelines and the clinical trial process.
- Ability to monitor study sites in compliance with protocol guidelines, SOPs, and ICH-GCP.
- Strong planning, organization, and problem-solving skills.
- Good communication skills, both oral and written.
Desired Skills
- Technical Proficiency:
- Experience with electronic data management systems and case report forms.
- Ability to work effectively in a matrix environment.
- Additional Experience:
- Experience in client-facing environments and familiarity with regulatory documentation and compliance.
General Responsibilities
| Responsibility | Details |
|---|---|
| Site Monitoring | Conduct on-site and remote visits as per the monitoring plan. |
| Data Oversight | Review and reconcile data with Fortrea or client systems. |
| Regulatory Compliance | Ensure adherence to local regulatory requirements and IRB/IEC guidelines. |
| Site Coordination | Manage site supplies and recruitment, and liaise with project teams. |
| Documentation and Reporting | Maintain accurate records in CTMS and assist in producing status reports. |
Why Join Fortrea?
Fortrea is committed to transforming the clinical trial process and ensuring the rapid delivery of innovative therapies. By joining our team, you’ll be part of a collaborative workspace that fosters personal growth and offers the opportunity to make a global impact. We value problem-solvers and creative thinkers who are passionate about advancing clinical research.
Apply Now and take the next step in your career with Fortrea, where your skills and expertise will contribute to meaningful advancements in healthcare.
Fortrea is an Equal Opportunity Employer (EOE/AA). We are dedicated to promoting diversity and inclusion in the workforce and do not tolerate any form of discrimination or harassment. We make employment decisions based on business needs and individual qualifications. All qualified individuals are encouraged to apply. For more information, visit Fortrea’s website.