Senior CRA - Oncology | Impactful Clinical Trials Lead

IQVIA; Parsippany-Troy Hills (NJ); Sur place; USD 105 000 - 198 000; Plein temps

Résumé du poste

IQVIA Biotech is seeking a Senior Clinical Research Associate to independently manage and monitor clinical trial sites, ensuring compliance with protocols, GCP, ICH guidelines, FDA regulations, and sponsor expectations.

You will lead monitoring visits, support patient recruitment, train site staff, resolve quality issues, track milestones, review source documents, manage data queries, maintain essential documents, and mentor junior CRAs as needed.

Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline (or equivalent combination of education and experience).
• 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.

Responsabilités

• Independently manage and monitor clinical trial sites to ensure studies are conducted in compliance with study protocols, GCP, ICH guidelines, FDA regulations, and sponsor expectations.
• Perform site monitoring activities including site qualification, initiation, routine monitoring, and closeout visits.
• Collaborate with investigative sites to support patient recruitment and retention, provide protocol training, and identify and resolve quality or compliance issues.
• Oversee site performance, track study milestones, review source documentation, manage data query resolution, and maintain regulatory documents.
• Document monitoring activities through timely and accurate reports and mentor junior CRAs through co-monitoring and training.

Connaissances

Site monitoring

GCP compliance

ICH guidelines

FDA regulations

Communication

Organization

Formation

Bachelor's degree in a scientific/healthcare field

Outils

Microsoft Office

Clinical trial systems

Description du poste

IQVIA Biotech is seeking a Senior Clinical Research Associate to independently manage and monitor clinical trial sites, ensuring compliance with protocols, GCP, ICH guidelines, FDA regulations, and sponsor expectations.

You will lead monitoring visits, support patient recruitment, train site staff, resolve quality issues, track milestones, review source documents, manage data queries, maintain essential documents, and mentor junior CRAs as needed.