Clinical Research Coordinator

P1 Pratia Oncology (formerly P1 Trials) is a network of world-class, community-based oncology investigative sites capable of performing complex Phase 1 clinical trials. We emphasize standardization and centralization of clinical trial operations to ensure efficiency, high-quality data, and faster study start-up timelines. With a patient-centric approach and collaboration with our pharmaceutical, biotech, and CRO partners, we are dedicated to delivering reliable outcomes that support groundbreaking medical advancements. As our team continues to grow in the US, we are hiring a clinical research coordinator who will support the safe, compliant, and efficient conduct of early-phase oncology clinical trials across the P1 Pratia Network.

As a Clinical Research Coordinator , you will:

• Assist with daily clinical trial activities from study start-up through close-out.
• Schedule and facilitate study visits, assessments, and follow-up appointments.
• Support investigational product accountability when delegated.
• Track and document protocol deviations; support corrective actions.
• Assist with site qualification, initiation, monitoring, and close-out visits.
• Conduct pre-screening and confirm eligibility according to protocol criteria.
• Coordinate labs, imaging, procedures, and specialist referrals.
• Document protocol compliance, including investigational product adherence.
• Maintain essential regulatory documents per ICH-GCP, FDA, and institutional standards.
• Support IRB submissions, amendments, safety reports, and renewals.
• Maintain delegation logs and protocol version control.
• Promote adherence to SOPs and process improvement initiatives.
• Enter and verify data in EDC systems within sponsor timelines.
• Resolve data queries promptly and collaborate with monitors.
• Oversee completion of case report forms (CRFs).
• Assist with audits and inspections.
• Coordinate with Pharmacy for IP accountability and dispensing when delegated.
• Coordinate with Laboratory for specimen processing and shipping.
• Coordinate with Radiology for protocol-window imaging.
• Document and follow up on adverse events (AEs) and serious adverse events (SAEs).
• Report safety events per protocol and regulatory timelines.
• Assist with feasibility, qualification, and study start-up activities.
• Track study visit completion and billable items.

Knowledge, Skills and Abilities

• Working knowledge of ICH-GCP and FDA regulations
• Attention to detail and accuracy in documentation, data entry, and regulatory records.
• Proficiency with clinical trial systems (e.g., EDC, CTMS) and standard office software.

Requirements

• High school diploma or GED
• Prior experience as a CRC or equivalent clinical research role (oncology preferred).

The anticipated salary range for this role is 65-80k/yearly. Actual compensation will depend on experience, location, and other factors.

Candidates must be authorized to work in the United States without current or future sponsorship.