Onsite Phase I Oncology Research Coordinator II

Actalent; Palo Alto (CA); On-site; USD 51,000 - 62,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Paid time off

Job summary

Actalent seeks an Oncology Clinical Research Coordinator II for an onsite role in Palo Alto, CA. The candidate will manage significant portions of oncology studies, coordinate Phase I trials, and ensure protocol adherence and patient safety.

Responsibilities include recruitment, data management, regulatory compliance, IRB submissions, and collaboration with investigators and sponsors. Strong CRC experience in oncology and familiarity with EMR systems are essential.

Qualifications

• Minimum 3.5+ years of CRC experience.
• Oncology clinical research experience is required.
• Experience supporting Phase I trials, including first-in-human cancer studies.
• Bone Marrow Transplant (BMT) experience strongly preferred.
• Strong clinical research coordination and study management skills.
• 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.

Skills

CRC experience

Oncology clinical research

Phase I trials experience

Study coordination & management

Regulatory documentation

Data entry & data management

Tools

Epic EMR

Job description

Actalent seeks an Oncology Clinical Research Coordinator II for an onsite role in Palo Alto, CA. The candidate will manage significant portions of oncology studies, coordinate Phase I trials, and ensure protocol adherence and patient safety.

Responsibilities include recruitment, data management, regulatory compliance, IRB submissions, and collaboration with investigators and sponsors. Strong CRC experience in oncology and familiarity with EMR systems are essential.