QA Lead Clinical Research

Overview Rocky Mountain Cancer Centers, Colorado’s largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced QA Lead Clinical Research Coordinator/RN in Denver. Salary range: $87,000–$117,000. Pay is based on factors including education, work experience, certification, etc. Benefits include health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; potential research bonus after one year; 401(k) retirement plan; life insurance, short‑term and long‑term disability insurance; Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance. Responsibilities Screens potential patients for protocol eligibility, presents trial concepts, participates in informed consent, and enrolls patients on clinical trials. Responsible for reviewing consents to ensure proper execution of the informed consent process. Coordinates patient care in compliance with protocol requirements. Disburses investigational drug, provides patient teaching regarding administration, maintains investigational drug accountability, and oversees order preparation by physicians to ensure protocol compliance. Reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study drug; documents and reports findings to physicians and care team; enters orders and communicates with physicians about study requirements, dose modification, and adverse event reporting; provides clinical services as required including patient assessments. Reviews protocol‑specific billing guides, submits billing information, and compiles and reports protocol activity, accrual data, and research financials to practice administration and physicians. May develop practice research. Maintains regulatory documents per USOR SOP and applicable regulations; participates in scheduling, monitoring, and auditing visits. Interacts with monitors/auditors on site, provides input on improving policies/processes; solves complex issues around patient trial participation. Functions in a lead role as a resource for research staff, conducts protocol‑specific training, reviews protocols, and provides input on study activities. May work with SRL to determine recruitment goals, oversee subject recruitment and enrollment, lead efforts to promote/recruit participants, assist with feasibility assessments and study selection. Trains and promotes professional development of staff. QA Lead Duties Completes double‑check reviews of eligibility prior to patient study enrollments by network CRCs, tracks issues for retraining, process improvement, and SOP development. Functions as study lead for trials as assigned by manager, including development of CRC tools (pink sheets, training documents), ongoing updates to study documents, and development of SOPs and process work instructions. Acts as primary preceptor for orientation and onboarding of new research staff. Provides review and feedback on potential upcoming trials related to operational concerns and feasibility. Provides study‑specific training and updates to the larger research team. Works with management on ongoing QA projects to support audit readiness and ongoing education of team members, developing appropriate SOPs and work instructions. Qualifications Graduate from an accredited nursing program (BSN preferred). OCN, SoCRA, or ACRP certification preferred. Current RN license in state of practice. Current BLCS or ACLS certification required. Minimum five years of nursing experience, preferably in oncology. Previous management and/or leadership experience. Strong experience in clinical research (highly preferred). Ability to read, analyze, and interpret technical procedures (protocols, informed consent, regulatory documents). Ability to work independently, organize, prioritize, and follow through. Problem‑solving and implementation skills. Strong multitasking ability. Excellent communication, time management, and interpersonal skills. High level of attention to detail and accuracy. Ability to work in a fast‑paced environment. Working Conditions The work environment includes exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations, and other conditions common to an oncology/hematology clinic environment. Physical Requirements Requires standing and walking for extensive periods, occasionally lifting and carrying items up to 40 lbs, and corrected vision and hearing within normal range. #J-18808-Ljbffr The US Oncology Network