Clinical Research Coordinator
il y a 28 jours
Albuquerque
Job Description Clinical Research Coordinator Southwest Women's Oncology | Albuquerque, New Mexico Why This Role Matters Clinical trials are how medicine moves forward - and for patients facing gynecologic cancer, access to a trial can mean access to a treatment that doesn't yet exist anywhere else. The Clinical Research Coordinator is the operational core of that work. You are the person who keeps trials running cleanly, protecting data integrity, supporting patients through the research process, ensuring regulatory compliance, and serving as the connective tissue between sponsors, investigators, and the clinical team. At Southwest Women's Oncology, clinical research is not a side program. It is a commitment to our patients and to the future of gynecologic oncology care. We hire for attitude and aptitude above all else. Credentials matter, but who you are and how you grow matter more. Who We Are Southwest Women's Oncology (SWWO) is New Mexico's leading gynecologic oncology practice, delivering advanced cancer care with skill, courage, and compassion. Optimum Human and Optimum Infusion extend that mission into performance medicine, infusion services, longevity, recovery, hormone optimization, medical weight loss, peptide therapies, hyperbaric medicine, aesthetics, and human performance. Together, we operate as a single integrated platform committed to one mission: To deliver new possibilities in medical care, human performance, and health by uniting passion, knowledge, and skill. The Opportunity This is not an entry-level support role. The Clinical Research Coordinator owns the day-to-day coordination of an active gynecologic oncology trial portfolio-working with independence, precision, and genuine ownership across study start-up, patient management, data integrity, and regulatory compliance. You will work closely with: • Principal Investigators and the clinical team on protocol execution and patient care integration, • The Clinical Research Director on study planning, sponsor relationships, and operational performance, • Pharmaceutical sponsors, CROs, and IRBs on regulatory submissions, monitoring visits, and data resolution, • Patients navigating active trial participation, from consent through follow-up You will bring organizational precision, regulatory fluency, and a patient-centered approach to every study you touch. What You'll Own Study Coordination & Start-Up • 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. Patient Management • Screen patients for clinical trial eligibility under investigator supervision., • Coordinate patient research visits, labs, imaging, and follow-up appointments with precision and care., • Support the informed consent process, ensuring documentation is complete, accurate, and audit-ready., • Serve as a trusted, knowledgeable resource for patients navigating active trial participation. Data Integrity & Documentation • 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. Regulatory & Compliance • 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 with organized, complete documentation. Operational & Administrative Support • Manage research-related communication with sponsors, CROs, and reference laboratories., • Maintain research supply inventory and coordinate research billing, ensuring appropriate separation of standard-of-care and research-related charges. What Success Looks Like First 90 Days • Fully oriented to active protocols, regulatory files, and trial portfolios., • Independently managing patient visit coordination and data entry with accuracy and timeliness., • Strong working relationships established with investigators, clinical staff, and sponsor contacts. First 6 Months • Full study coordination responsibilities owned across active trials., • Regulatory files current, audit-ready, and consistently maintained., • Trusted by the clinical team and patients as a reliable, knowledgeable research resource. First Year • Recognized as a clinical research anchor within the SWWO team., • Measurable contribution to enrollment performance, data quality, and trial compliance., • Consistently embodying the Optimum Standard. Who Thrives Here We want people who bring relentless positivity, a hunger to learn, and the drive to elevate everyone around them. You will likely thrive if: • You take ownership rather than waiting for direction., • You believe details matter., • You enjoy solving problems and seek continuous improvement., • You care deeply about patients and their families., • You value teamwork and accountability equally., • You're coachable, curious, and committed to mastery. What You Bring Required • 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. Our Culture We act with courage and embrace accountability. We serve with precision and hold ourselves to impeccable standards-then raise them. We reject mediocrity and the comfort of "good enough." We measure success not only by outcomes, but by the integrity, excellence, and humanity we bring to every interaction. Way Better. Extraordinary by Design. If you crave mastery, meaning, and measurable impact-welcome home. Compensation & Benefits • Competitive salary, • Health benefits, • 401(k), • Paid time off, • Professional development and continuing education support, • Opportunity to grow within the Optimum Platform This is a full-time, on-site position at our Albuquerque, New Mexico office. No description uploaded.
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