Clinical Research Coordinator

Southwest Womens Oncology Inc•Albuquerque, NM

6d•Onsite

About The Position

Southwest Women's Oncology is hiring a Clinical Research Coordinator to own day-to-day coordination of an active gynecologic oncology clinical trial portfolio. The role coordinates Phase I–III trials from start-up through close-out, supporting study operations, patient participation, data integrity, and regulatory compliance. The coordinator works with Principal Investigators, the clinical team, the Clinical Research Director, pharmaceutical sponsors, CROs, IRBs, and patients. This is a full-time, on-site position at the Albuquerque, New Mexico office.

Requirements

At least 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 or Google Suite.
Exceptional organizational skills and attention to detail, with the ability to manage multiple active protocols simultaneously.
Strong interpersonal and communication skills and a compassionate, patient-centered approach.

Nice To Haves

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.

Responsibilities

Coordinate Phase I–III gynecologic oncology clinical trials from start-up through close-out.
Lead study start-up activities, including preparing regulatory documents, submitting materials to IRBs, and coordinating site initiation logistics.
Prepare and maintain study binders, regulatory files, investigator site files, and patient charts.
Track study timelines, visit windows, protocol-required procedures, and sponsor deliverables.
Screen patients for clinical trial eligibility under investigator supervision.
Coordinate research visits, labs, imaging, and follow-up appointments.
Support informed consent and ensure documentation is complete, accurate, and audit-ready.
Serve as a resource for patients participating in clinical trials.
Enter study data accurately and on schedule into electronic data capture systems.
Maintain source documentation and audit-ready filing practices.
Resolve sponsor and CRO data queries accurately and promptly.
Ensure documentation complies with Good Clinical Practice and applicable regulatory standards.
Maintain current regulatory files, including investigator credentials, training records, and protocol amendments.
Assist with adverse event reporting, protocol deviation documentation, and corrective action follow-through.
Support monitoring visits, sponsor audits, and regulatory inspections.
Manage research-related communications with sponsors, CROs, and reference laboratories.
Maintain research supply inventory and coordinate research billing, separating standard-of-care and research-related charges appropriately.