Job Description
- Hourly pay: $44-$50/hr
- Worksite: Leading university (Stanford, CA 94305 - Hybrid)
- W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
- 40 hours/week, 6 Month Assignment (Possible extension/conversion)
A leading university is seeking a
Clinical Research Coordinator to independently manage key aspects of oncology clinical trials while ensuring regulatory compliance, participant safety, and high-quality study execution. This role will support complex research activities, including patient recruitment, data management, regulatory oversight, and collaboration with investigators and sponsors in a hospital-based research environment.
Clinical Research Coordinator Responsibilities:- Oversee subject recruitment, enrollment, and retention activities for clinical studies, developing effective strategies to meet enrollment goals and supporting participants throughout long-term treatment trials.
- Manage clinical research data and study operations, including developing data collection systems, extracting and analyzing study data, creating project schedules, tracking milestones, leading team meetings, and maintaining study documentation.
- Ensure regulatory compliance by auditing study operations, monitoring Institutional Review Board submissions and renewals, supporting FDA-related requirements, including Investigational New Drug applications when applicable, and implementing corrective actions and process improvements.
- Collaborate with principal investigators, study sponsors, and research teams to resolve study queries, monitor and report serious adverse events, develop study budgets, distinguish standard of care versus research procedures, and manage sponsor invoicing activities.
- Provide leadership and mentorship by training and supporting research staff or students, establishing best practices, and driving improvements to study processes and operational efficiency.
Clinical Research Coordinator Qualifications:- 2+ years of clinical research experience, or an equivalent combination of education and relevant experience.
- Bachelor's degree in a related field.
- Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification is preferred.
- Experience coordinating cancer treatment clinical trials is strongly preferred.
- Experience supporting Phase I treatment trials is strongly preferred.
- Experience working as a clinical research coordinator within a hospital or clinic setting is strongly preferred.
- Experience with EPIC EMR is strongly preferred.
- Knowledge of research protocols and regulatory requirements, including HIPAA, FDA regulations, Institutional Review Board requirements, and Good Clinical Practice (GCP) guidelines.
- Strong interpersonal and communication skills with the ability to collaborate effectively with investigators, sponsors, research participants, and cross-functional teams.
- Proficiency with Microsoft Office Suite and database applications.
- Knowledge of medical terminology.
Shift:- Hybrid: 3 to 4 days onsite.
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