Clinical Research Coordinator 2
Actalent · Palo Alto, CA · 3 wk ago
On-siteResearch$37–$45/hrContract
Qualifications
- Minimum 3.5+ years of Clinical Research Coordinator (CRC) experience
- Oncology clinical research experience required
- Experience supporting Phase I clinical trials, including first-in-human cancer studies
- Experience working within a Bone Marrow Transplant (BMT) program strongly preferred
- Strong clinical research coordination and study management experience
- Proficiency with electronic medical records (Epic preferred)
- Experience with clinical data entry, data management, and regulatory documentation
Responsibilities
- Independently manage significant components of large oncology studies or oversee all aspects of smaller clinical research studies.
- Coordinate and execute Phase I oncology clinical trials, ensuring protocol compliance and participant safety.
- Oversee subject recruitment, screening, enrollment, and retention efforts to meet study goals.
- Develop and manage systems for data collection, organization, monitoring, reporting, and quality control.
- Extract, analyze, interpret, and report study data accurately and efficiently.
- Collaborate closely with Principal Investigators, study sponsors, research staff, and clinical teams.
- Monitor, document, and report serious adverse events and resolve sponsor and study queries.
- Prepare and maintain regulatory documents and ensure ongoing compliance with federal, institutional, and sponsor requirements.
- Manage Institutional Review Board (IRB) submissions, renewals, modifications, and responses.
- Assist with Investigational New Drug (IND) application processes when applicable.
- Participate in study budget development, milestone tracking, and sponsor invoicing activities.
- Lead project meetings, maintain study timelines, and prepare meeting minutes and documentation.
- Conduct research and laboratory audits to ensure compliance with applicable regulations and Good Clinical Practice (GCP) standards.
- Identify process improvements and implement best practices across research operations.
- Train, mentor, and support newer research staff and students as assigned.
Job Type: Contract position based out of Palo Alto, CA.
Pay
The pay range for this position is $37.00 - $45.00/hr.
Benefits
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)