Senior Clinical Researcher & Quality Administration -UPMC Hillman Waterford

at  UPMC

QUALIFICATIONS & EXPERIENCE:

Qualifications: Completion of a qualification in Radiation Therapy recognised by the Radiographers Registration Board at CORU
OR
Currently registered nurse/midwife on the active Register of Nurses/Midwives held by Bord Altranais agus Cnáimhseachais na hÉireann (Nursing and Midwifery Board of Ireland)
Have an Oncology Qualification from an accredited institution or be willing to undertake the course and in-house training
Experience:
(Amount and Type) Experience in research, quality and clinical radiation therapy or oncology nursing desirable.
Job Specific Competencies and Knowledge: Licensure/Certification:
Irish / European / US / Canada appropriate license.
Professional outlook
This job description is intended to be an outline of the areas of responsibility and deliverables at the time of its writing. As the Bon Secours Radiotherapy in Partnership with UPMC Hillman Cancer Centre and the post holder develop, this job description may be subject to review in light of the changing needs of the Centre.
Equal Opportunity Statement and Benefits

OVERVIEW OF ROLE:

The Senior Clinical Researcher, as a member of the multi-disciplinary team, is responsible for the oversight and management of all aspects of research and clinical trials within the radiotherapy department at UPMC Hillman Cancer Centre in Waterford. The Senior Clinical Researcher is responsible for the coordination and supervision of clinical trials and departmental research projects from the regulatory, patient facing, financial, patient education, organizational, and crediting aspects. The Senior Clinical Researcher & Quality Administrator is responsible for supporting the quality and patient safety function within UPMC Hillman Cancer Centre Waterford regarding accreditation and quality improvements within the department.

PRIMARY DUTIES AND RESPONSIBILITIES:

General Duties:
Work with investigators to identify and prioritize new trials.
Coordinate implementation of newly opened clinical research studies
Work with financial and regulatory staff to ensure all contracts and budgets are completed.
Coordinate patient care according to study protocol.
Work with physician for patient recruitment and obtaining informed consent.
Ensure protocol compliance.
Provide patient education.
Maintain and update clinical research documentation, including site files, case record forms, monitoring arrangements, data correction, data collection, and data entry.
Review proposed research protocols and provide input to site study feasibility reports.
Attend/chair research meetings.
Play a proactive role in driving ongoing clinical research projects through participant recruitment, participant follow ups, identifying problems early and regularly.
Work in collaboration with the Quality and Regulatory Affairs Manager in identification, development and implementation of the Cancer Centre quality improvements/quality assurance programme.
Ensures the measurement and analysis of data is incorporated in all quality improvement projects.
Support the review and follow up of the incident management programme within the department.
Support with policies, procedures and all document control activities
Experience Desired:
Familiarity with ethics committee submissions
Experience with data management, CRFs and eCRFs
Thorough knowledge of Good Clinical Practice (GCP) best practice as it applies to clinical trials, and data obligations
Outstanding communication skills required for successful multidisciplinary clinical research
Familiarity with clinical trial set-up
Experience of training other staff members on GCP, trial protocols and obligations relating to clinical trials
Knowledge of radiotherapy credentialing processes
Experience of Investigational Medicinal Product (IMP) studies
Clinical trial monitoring experience
Experience with cooperative groups and Clinical Research Organisations (CROs)Uses effective communication techniques and interpersonal skills to provide explanations for treatment-related procedures.
Demonstrate a knowledge of applying standards to practice, quality improvement processes and quality and safety frameworks.
Experience with appropriate accreditation and regulations.
Excellent IT skills: MS Office skills to include MS Teams, Word, Excel and PowerPoint, knowledge and experience of using an email system effectively e.g., Outlook.
Standard Responsibilities
Performs in accordance with system-wide competencies/behaviours.
Performs other duties as assigned.
Lives the UPMC Values
At times, there may be a requirement to work clinically due to unforeseen circumstances.