Senior Clinical Research Associate - Oncology
New
Based in the United StatesFull-TimeSenior
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- English
- Experience
- Minimum of 5+ years of clinical monitoring / CRA experience
Requirements
- Bachelor’s degree in a scientific, life sciences, or healthcare-related field.
- Minimum of 5+ years of clinical monitoring / CRA experience in a CRO or pharmaceutical environment.
- At least 2+ years of oncology monitoring experience.
- Strong knowledge of ICH-GCP guidelines and clinical trial processes.
- Experience with risk-based monitoring approaches.
- Ability to perform SDV, SDR, CRF review, and manage site-level documentation.
- Strong understanding of clinical study management, drug accountability, and data integrity.
- Excellent communication, interpersonal, and relationship-building skills.
- Strong organizational skills with the ability to manage multiple studies.
- Proficiency in English (written and spoken).
Responsibilities
- Lead site management activities including selection support, initiation, monitoring, and close-out of clinical trial sites.
- Conduct on-site and remote monitoring visits, including source data verification (SDV), source data review (SDR), and Case Report Form (CRF) review.
- Ensure compliance with ICH-GCP guidelines, study protocols, client SOPs, and regulatory requirements.
- Serve as the primary point of contact for assigned sites, providing training and support to investigators and site staff.
- Perform risk-based site assessments and adjust monitoring strategies.
- Track study progress, update clinical systems (e.g., CTMS), and ensure resolution of data queries.
- Manage investigational product accountability, study supplies, and documentation.
- Support Serious Adverse Event (SAE) reporting and ensure timely documentation of safety information.
- Prepare, finalize, and submit monitoring visit reports and follow-up letters.
- Ensure inspection readiness of sites and maintenance of essential documents within the eTMF.
View Full Description & ApplyYou'll be redirected to the employer's site
