QA Lead Clinical Research/RN

The US Oncology Network • Denver, CO

4d • Onsite

About The Position

Rocky Mountain Cancer Centers (RMCC), 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. RMCC is seeking a dedicated individual who views patient care as a calling, characterized by care, compassion, and commitment. The goal for every RMCC team member is to provide the best possible care for each patient, fostering a deep connection and commitment to their well-being.

Requirements

• Graduate from an accredited program for nursing education required (BSN preferred)
• Current licensure as a registered nurse in state of practice
• Current BLCS or ACLS certification required
• Minimum five years of nursing experience required, preferably in oncology
• Previous management and/or leadership experience
• Experience in clinical research strongly preferred
• Ability to read, analyze, and interpret technical procedures such as protocols, informed consent documents, and regulatory documents.
• Ability to work independently, organize, prioritize, and follow through with results
• Ability to solve practical problems and implement solutions
• Strong ability multi-task
• Must have excellent communication skills
• Excellent time management skills
• Must have a strong interpersonal skills to be able to interact with multiple people on many different levels
• Must have a high level of attention to detail
• Must be able to work in a fast paced environment
• Attention to details and accuracy

Nice To Haves

• OCN, SoCRA or ACRP certification preferred

Responsibilities

• Screens potential patients for protocol eligibility, presents trial concepts and details, participates in the informed consent process, and enrolls patients on clinical trials. Responsible for review of consents to ensure proper execution of the informed consent process for study subjects.
• Coordinates patient care in compliance with protocol requirements. Disburses investigational drug and provide patient teaching regarding administration and other patient educational. Maintains investigational drug accountability. Oversees the preparation of orders by physicians to assure that protocol compliance is maintained.
• Working independently, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents and reports all findings to physician and care team. Enters orders to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting. Provide clinical services as required including patient assessments.
• Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel. Responsible for compiling and reporting protocol activity, accrual data, and research financials to practice administration and physicians. May be responsible for the development of practice research.
• Maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participate in scheduling monitoring and auditing visits.
• Interacts with the monitors/auditors while onsite. Provide input in determining and implementing improvements to policies/processes. Works with clinic staff to solve complex issues around patient trial participation.
• Functions in a lead role as a resource for research staff. Conduct protocol-specific training for study personnel to include training of staff in preparation for study activities. Review protocols and provide input on study activities in relation to areas of expertise. May work with SRL to determine study recruitment and enrollment goals. Oversees subject recruitment and study enrollment to meet goals. Leads efforts to find effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Assists SRL in feasibility assessments and study selection.
• Trains and promotes professional development of staff.
• Completes double check reviews of eligibility prior to patient study enrollments by network CRC’s, tracks issues and concerns for future retraining, process improvement, and SOP development.
• Functions as study lead for trials as assigned by manager, includes development of CRC tools for study coordination – pink sheets, training documents, staff training, ongoing updates to study documents as required, development of SOP's 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 larger research team.
• Works with management team on ongoing QA projects to support audit readiness, ongoing education of team members, development of appropriate SOP's and work instructions to support same.

Benefits

• Health, dental, and vision plans
• wellness program
• health savings account
• flexible spending accounts
• potential for research bonus depending on financials of department after one year of employment
• 401(k) retirement plan
• life insurance
• short-term disability insurance
• long-term disability insurance
• Employee Assistance Program
• PTO
• holiday pay
• tuition reimbursement
• employee paid critical illness and accident insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree