Senior Clinical Research Associate, Oncology

About the role

IQVIA Biotech, a full-service CRO serving biotech sponsors, is hiring a Senior Clinical Research Associate for its Clinical Monitoring team in Durham. The role involves independently managing and monitoring clinical trial sites so that studies run in line with protocols, GCP, ICH guidelines, regulatory requirements and sponsor expectations. The pay range is stated as $105,100 to $197,500 per year.

Key responsibilities

• Perform site monitoring activities including site qualification, initiation, routine monitoring and closeout visits.
• Partner with investigative sites to support patient recruitment and retention, and give protocol and study-related training.
• Proactively identify and resolve quality or compliance issues.
• Oversee site performance, track study milestones and review source documentation.
• Manage data query resolution and ensure regulatory and essential documents are kept up to date.
• Document monitoring activities through timely and accurate reports.
• Collaborate with cross-functional teams and may mentor junior CRAs through co-monitoring and training.

Required profile

• Bachelor's degree in a scientific, healthcare or related discipline, or equivalent education and experience.
• At least 4 years of on-site clinical monitoring experience.
• Experience conducting monitoring visits across multiple phases of clinical research.
• Ability to manage multiple priorities in a fast-paced environment.

Required skills

• Strong knowledge of GCP, ICH guidelines, FDA regulations and clinical trial processes.
• Excellent organizational, communication and problem-solving skills.
• Proficiency with Microsoft Office and clinical trial systems.
• Preferred: strong therapeutic area knowledge, proven relationships with sites and sponsors, and mentoring experience.