Description
IQVIA Biotech is seeking an experienced Senior Clinical Research Associate to join their Clinical Monitoring team.
In this role, you will independently manage and monitor clinical trial sites to ensure studies are conducted in compliance with study protocols, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, regulatory requirements, and sponsor expectations.
Key responsibilities include:
- Performing site monitoring activities, including site qualification, initiation, routine monitoring, and closeout visits
- Partnering with investigative sites to support patient recruitment and retention efforts
- Providing protocol and study-related training
- Proactively identifying and resolving quality or compliance issues
- Overseeing site performance, tracking study milestones, reviewing source documentation, and managing data query resolution
- Collaborating with cross-functional teams to support the successful execution of clinical trials
- Mentoring junior CRAs through co-monitoring and training activities
Qualifications:
- Bachelor's degree in a scientific, healthcare, or related discipline
- Minimum of 4 years of on-site clinical monitoring experience
- Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes
- Experience conducting monitoring visits across multiple phases of clinical research
- Excellent organizational, communication, and problem-solving skills
- Ability to effectively manage multiple priorities in a fast-paced environment
- Proficiency with Microsoft Office applications and clinical trial systems
Preferred skills:
- Strong therapeutic area knowledge and protocol management experience
- Proven ability to build productive relationships with investigative sites, sponsors, and internal study teams
- Experience mentoring or supporting the development of junior clinical research professionals
The potential base pay range for this role is $105,100.00 - $197,500.00 per year.