Clinical Research Associate 2 (CRA II) – Oncology | IQVIA Biotech
Location: Durham, North Carolina (Field-Based)
Job Type: Full-Time
Job ID: R1481918
IQVIA Biotech is seeking an experienced Clinical Research Associate 2 (CRA II) with hands-on oncology monitoring experience and at least one year of on-site clinical monitoring. This role supports biotech-focused clinical programs and ensures high-quality trial execution in alignment with regulatory and sponsor standards.
About IQVIA Biotech
IQVIA Biotech is a specialized, full-service Contract Research Organization (CRO) built to support biotech sponsors. With more than 25 years of experience, IQVIA Biotech delivers agile, therapeutically aligned clinical solutions that accelerate the development of innovative therapies and improve patient outcomes.
Job Overview
The CRA II will be responsible for monitoring clinical trial sites, ensuring compliance with study protocols, GCP, ICH, and all applicable regulatory requirements. This role directly contributes to the quality, accuracy, and reliability of clinical research data across oncology studies.
Key Responsibilities
Site Monitoring and Oversight
Conduct initiation, selection, routine monitoring, and close-out visits per contracted scope, GCP, and ICH guidelines.
Evaluate site adherence to protocols and escalate quality issues as required.
Recruitment Support
Collaborate with site personnel to develop and manage subject recruitment strategies aligned with study enrollment timelines.
Training and Communication
Deliver study-specific and protocol training to site staff.
Maintain continuous communication with sites to manage expectations, mitigate risks, and resolve operational issues.
Regulatory & Study Progress Management
Track regulatory submissions, enrollment metrics, CRF submission, and data query resolution.
Support site readiness during trial start-up phases.
Documentation & Compliance
Ensure accurate maintenance of essential documents in the Trial Master File (TMF) and Investigator Site File (ISF).
Prepare detailed monitoring visit reports, follow-up letters, and site correspondence.
Cross-Functional Collaboration
Work closely with project managers and clinical teams to ensure alignment with study goals.
Depending on project needs, support site-level recruitment planning, budget tracking, and invoice collection.
Required Qualifications
Education
Bachelor’s degree in life sciences, healthcare, or a related discipline (or equivalent experience).
Experience (Mandatory)
Minimum 1 year of on-site clinical monitoring experience.
Oncology monitoring experience is required, with strong understanding of oncology site operations.
Core Skills
Solid knowledge of GCP, ICH guidelines, and applicable clinical research regulations.
Strong communication, problem-solving, and organizational skills.
Proficiency in Microsoft Office and clinical trial management systems.
Ability to travel based on project requirements.
Compensation
Annual base salary range: USD 69,800 – USD 226,800.
Actual compensation varies based on experience, qualifications, geographic location, and work schedule. Additional bonuses, incentive programs, and comprehensive health and welfare benefits may apply.
Equal Opportunity Statement
IQVIA is an equal opportunity employer. All qualified applicants will receive consideration without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, veteran status, or any other protected characteristic.
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