Title: Clinical Research Coordinator II
Pay Rate Range: $42.00 $51.95/hr. (DOE)
Employment Type: Contract (6 months; potential extension or conversion)
Schedule: Full-time, Monday Friday, Day Business Hours
Location: Palo Alto, CA (100% Onsite)
Job Code: 1492368
Position Overview
Tekberry is seeking a highly organized and experienced Clinical Research Coordinator to support oncology clinical research studies within a leading academic and healthcare environment in Palo Alto, CA. This role is responsible for independently coordinating and managing significant aspects of clinical research studies, including patient enrollment, regulatory compliance, study operations, data management, and sponsor coordination.
The ideal candidate will have prior experience supporting oncology clinical trials, including treatment studies across Phases I III, and the ability to independently manage study activities in a fast-paced clinical research environment.
As a Tekberry W2 employee, you will have access to health benefits including medical, dental, vision, and 401(k) options.
Key Responsibilities
Clinical Trial Coordination & Patient Management
Independently manage key aspects of one or more clinical research studies
Oversee subject recruitment, enrollment goals, and participant retention strategies
Determine participant eligibility and coordinate informed consent processes
Collaborate with Principal Investigators, sponsors, and clinical teams to ensure proper study conduct and patient safety
Data Management & Study Operations
Oversee data collection, management, analysis, and reporting for research projects
Develop and maintain systems to organize and monitor study data and documentation
Extract, analyze, and interpret research and patient data
Develop study tracking tools, flow sheets, and operational documentation
Regulatory Compliance & Quality Assurance
Ensure compliance with HIPAA, FDA regulations, Institutional Review Board (IRB) requirements, and Good Clinical Practices (GCP)
Prepare and manage regulatory submissions and renewals
Audit study operations and documentation to ensure regulatory compliance
Monitor and report serious adverse events and resolve study-related queries
Project Leadership & Coordination
Develop project schedules, milestones, targets, and accountability measures
Lead study meetings and prepare meeting documentation and reports
Provide leadership in identifying and implementing process improvements and best practices
Coordinate monitor visits, sponsor meetings, and regulatory audits
Financial & Budget Oversight
Assist with development and management of study budgets
Track patient and study milestones and support sponsor invoicing activities
Collaborate with finance and management teams to resolve billing issues and maintain budget compliance
Training & Team Support
Train, mentor, and support research staff, students, or new team members as assigned
Assist with onboarding, performance support, and workflow coordination within the research team
Required Qualifications
Bachelor's degree in a related field and 2+ years of clinical research experience OR equivalent combination of education and experience
Experience supporting oncology clinical research and treatment trials (Phases I III preferred)
Experience coordinating onsite clinical research studies
Strong understanding of research protocols, HIPAA, FDA regulations, IRB requirements, and Good Clinical Practices (GCP)
Proficiency with Microsoft Office and database applications
Knowledge of medical terminology
Strong organizational, communication, and interpersonal skills
Ability to manage multiple priorities independently in a fast-paced environment
Preferred Qualifications
Experience managing oncology treatment trials
SOCRA or ACRP certification preferred
Experience with sponsor interactions, monitoring visits, and regulatory audits
Experience with study budgets, invoicing, and milestone tracking
Work Environment & Physical Requirements
100% onsite role located in Palo Alto, CA
Clinical and office-based research environment
Frequent standing, walking, bending, stooping, squatting, and fine motor activity
Occasional lifting, carrying, pushing, or pulling objects up to 40 pounds
Fast-paced environment requiring collaboration across clinical and research teams
We need hard-working, reliable employees. If you're interested in supporting meaningful clinical research and contributing to innovative oncology studies, apply today!
Tekberry is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other protected category. Tekberry is a certified Minority Business Enterprise (MBE) and a Disadvantaged Business Enterprise (DBE).
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