Clinical Research Coordinator

About the role

This role is crucial for the smooth operation of clinical trials at Southwest Women's Oncology, focusing on patient care, data integrity, and regulatory compliance.

Responsibilities

• Own day-to-day coordination of Phase I–III gynecologic oncology clinical trials from start-up through close-out.
• Lead study start-up activities including regulatory document preparation, IRB submissions, and site initiation logistics.
• Prepare and maintain study binders including regulatory files, investigator site files, and patient charts.
• Track study timelines, visit windows, protocol-required procedures, and sponsor deliverables.
• Serve as a trusted, knowledgeable resource for patients navigating active trial participation.
• Enter study data accurately and on schedule into electronic data capture (EDC) systems.
• Maintain source documentation and ensure filing practices are consistently audit-ready.
• Resolve data queries from sponsors and CROs with accuracy and timeliness.
• Ensure all documentation complies with Good Clinical Practice (GCP) and applicable regulatory standards.
• Maintain current regulatory files including investigator credentials, training records, and protocol amendments.
• Support adverse event reporting, protocol deviation documentation, and corrective action follow-through.
• Support monitoring visits, sponsor audits, and regulatory inspections with organized, complete documentation.
• Manage research-related communication with sponsors, CROs, and reference laboratories.
• Coordinate research supply inventory and coordinate research billing, ensuring appropriate separation of standard-of-care and research-related charges.

Requirements

• 2+ years of clinical research experience, with demonstrated ownership of trial coordination responsibilities.
• Working knowledge of Good Clinical Practice (GCP), ICH guidelines, and FDA regulatory requirements.
• Experience with electronic data capture (EDC) systems and regulatory file management.
• Strong knowledge of medical terminology.
• Proficiency with EMR systems and Microsoft Office/Google Suite.
• Exceptional organizational skills and attention to detail; able to manage multiple active protocols simultaneously.
• Strong interpersonal and communication skills with a compassionate, patient-centered approach.

Preferred

• Experience in oncology or gynecologic oncology clinical research.
• Familiarity with Phase I–III therapeutic drug trials and sponsor/CRO relationships.
• CCRP, CCRC, or equivalent clinical research certification.

Pay

Competitive salary

Schedule

Full-time, on-site position at our Albuquerque, New Mexico office.