QA Lead Clinical Research

QA Lead Clinical Research Coordinator/RN

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.

We realize that it sounds clich but it is true - taking care of cancer patients is a calling. It's much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment.

No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient's hand, or a scheduler on the phone finding an appointment that fits into a patient's schedule, we are deeply connected to our patients and do what we can to help.

If this sounds like you, we'd love to have you join our team.

Salary Range: $60,000-$75,000 for non-nurses and $80,000-$110,000 for nurses

Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements: 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, and employee paid critical illness and accident insurance.

A wide salary range is posted for this position and any job offer is based upon a salary analysis to comply with the Colorado Equal Pay for Equal Work Act. The salary analysis considers relevant experience, education, and certifications as compared to others doing substantially similar work. While all offers are compliant with the Colorado Equal Pay for Equal Work Act, there is no guarantee an offer will be at the top of the posted range based on the salary analysis.

Responsibilities

• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, 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 impletmenting improvement to policies/processes. Works with clinic staff to solve complex issues around patient trial participation.
• Due to expertise in subject matter, 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 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.

QA Lead Duties

• 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 ad
• 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.

Qualifications

• • Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology.
  • SoCRA or ACRP certification preferred.

• or

  • Graduate from an accredited program for nursing education (BSN preferred). Minimum seven years of nursing experience, preferably in oncology. Experience in clinical research preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred.

    Specialized Knowledge/Skills -

    • 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

    • Knowledge of medical terminology, nursing assessment, anatomy and physiology, clinical medical, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology, clinical trials and GCP concepts

    • Experience with computer data entry and database management

Working Conditions

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.

Physical Requirements -

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.

All qualified candidates are required to pass a background check and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire.