
CRA 2, Cell & Gene Therapy, East Coast/Central, U.S. - IQVIA Biotech
Are you passionate about advancing innovative therapies that have the potential to change lives? We are seeking a highly motivated and experienced CRA 2 for our Cell & Gene Therapy team on the East Coast/Central region of the United States. As part of IQVIA Biotech, a leading provider of clinical research services, you will have the opportunity to contribute to groundbreaking research in the rapidly growing field of cell and gene therapy. We are looking for a candidate with a strong background in clinical research, exceptional attention to detail, and a drive for excellence. If you are ready to make a difference and be part of an exciting and dynamic team, we encourage you to apply for this role.
- Conduct clinical research activities in compliance with protocol, ICH/GCP guidelines, and applicable regulations.
- Monitor and manage clinical trial sites to ensure the timely and quality execution of clinical trials.
- Review and verify clinical trial data and ensure accuracy and completeness.
- Communicate effectively with study team members, sponsors, and clinical trial sites to ensure study success.
- Identify and resolve issues and implement corrective actions as needed.
- Participate in site initiation, interim monitoring, and close-out visits.
- Develop and maintain strong relationships with study sites and investigators.
- Ensure compliance with SOPs, study protocols, and regulatory requirements.
- Train and mentor junior clinical research associates on study-specific processes and procedures.
- Proactively identify and address potential study risks and implement risk mitigation strategies.
- Contribute to the development of study-related documents such as protocols, informed consent forms, and study manuals.
- Collaborate with cross-functional teams to ensure study milestones and deliverables are met.
- Ensure timely and accurate completion of study reports and documentation.
- Keep abreast of industry developments and regulations related to cell and gene therapy.
- Represent IQVIA Biotech and the Cell & Gene Therapy team at industry conferences and meetings.
- Maintain accurate and up-to-date study files and records.
- Demonstrate a high level of professionalism and integrity in all interactions.
- Adhere to company policies, procedures, and standards.
Bachelor's Degree In A Scientific Or Healthcare-Related Field, With A Strong Understanding Of Cell And Gene Therapy Concepts And Technologies.
Minimum Of 2 Years Of Experience As A Clinical Research Associate (Cra), Preferably In The Biotech Or Pharmaceutical Industry.
Knowledge Of Fda Regulations And Guidelines For Cell And Gene Therapy Clinical Trials, As Well As Gcp And Ich Guidelines.
Ability To Travel Up To 75% Of The Time And Work Independently, With Excellent Time Management And Communication Skills.
Prior Experience In Managing Multiple Sites And Monitoring Clinical Trials In The East Coast Or Central Region Of The United States.
Quality Assurance
Project Management
Data Analysis
GCP
Data collection
Regulatory compliance
Clinical Trials
Patient Recruitment
Protocol Development
Cell Therapy
Gene Therapy
Pharmaceutical Industry
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a CRA 2, Cell & Gene Therapy, East Coast/Central, U.S. - IQVIA Biotech is $85,000-$120,000 per year. This may vary depending on factors such as experience, location, and specific responsibilities within the role.
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IQVIA, formerly Quintiles and IMS Health, Inc., is an American multinational company serving the combined industries of health information technology and clinical research.

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