Sr. CRA, Oncology, IQVIA Biotech

IQVIA•Durham, NC

7d•$105,100 - $197,500

About The Position

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster. We are seeking an experienced Senior Clinical Research Associate to join our 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. As a key member of the study team, you will perform site monitoring activities including site qualification, initiation, routine monitoring, and closeout visits. You will partner closely with investigative sites to support patient recruitment and retention efforts, provide protocol and study-related training, and proactively identify and resolve quality or compliance issues. The Sr CRA is responsible for overseeing site performance, tracking study milestones, reviewing source documentation, managing data query resolution, ensuring regulatory and essential documents are maintained, and documenting monitoring activities through timely and accurate reports. You will collaborate with cross-functional teams to support the successful execution of clinical trials and may mentor junior CRAs through co-monitoring and training activities.

Requirements

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.

Nice To Haves

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.

Responsibilities

Perform site monitoring activities including site qualification, initiation, routine monitoring, and closeout visits.
Partner closely with investigative sites to support patient recruitment and retention efforts.
Provide protocol and study-related training.
Proactively identify and resolve quality or compliance issues.
Oversee site performance.
Track study milestones.
Review source documentation.
Manage data query resolution.
Ensure regulatory and essential documents are maintained.
Document monitoring activities through timely and accurate reports.
Collaborate with cross-functional teams to support the successful execution of clinical trials.
Mentor junior CRAs through co-monitoring and training activities.