Overview
Job summary: The post holder will lead the delivery of a high-quality administrative and data service for the Early Phase Oncology Research Delivery team, undertaking delegated responsibilities for study set-up and auditing active studies. They will coordinate, monitor, and support the implementation of research studies, working closely with internal departments and research networks to meet NIHR national targets, and will be responsible for implementing and maintaining robust data quality processes. The post is predominantly based at the QE Hospital working on Experimental Cancer Medicine Centre (ECMC) trials. ECMC is a leading UK wide initiative that focuses on advancing the development of new and novel oncology treatments. Funded by both CRUK and NIHR.
Main duties / Responsibilities
* Communicate effectively with personnel involved in clinical trials (CIs, PIs, Co-Investigators, Sponsors, CROs, CRAs, PPI Groups, R&D, Research Nursing staff, pharmacy, imaging).
* Serve as a key contact for maintaining study data integrity.
* Train and audit Data Officer activities and complete delegated study tasks.
* Liaise with the RD&I contact for quality management system administration, including managing document archives.
* Attend and represent the delivery team at national and, where appropriate, international study-related meetings.
* Predict and proactively respond to obstacles in achieving targets, including protocol, funding, or timing changes.
* Establish procedures to ensure protocol adherence and identify, evaluate, and resolve problems.
* Arrange, attend, and transcribe minutes for study feasibility meetings, Site Initiation Visits (SIVs), and other study meetings.
* Prioritise daily workload, respond to urgent issues, and escalate to management as needed.
* Liaise regularly with Clinical Manager/Quality Assurance Manager to align priorities with departmental workload.
* Collate and provide invoicing information for delegated studies; monitor study invoicing logs and verify study visit/expenses data against protocols and CTAs.
* Collect and report information for consultants/managers (activity data, funding sources, invoicing reports, NIHR yearly metrics).
Qualifications
Essential
* Educated to degree level or relevant subject in relation to Research, IT, business administration or equivalent experience and training
Desirable
* Management Certificate or equivalent experience (e.g. NVQ 4 level Management or equivalent knowledge / experience)
Experience
* Essential: Experience of team leadership
* Essential: Evidence of further professional development
* Essential: Evidence of having worked in a clinical research environment
* Essential: To demonstrate understanding of the role and responsibilities of the post
* Desirable: Experience of managing and analysing complex research data
* Desirable: In-depth knowledge of research study set up and regulatory frameworks
* Desirable: Able to demonstrate knowledge of Research and Research Governance processes
Additional Criteria
* Full range secretarial / admin / office skills
* Ability to line manage staff
* Competent word processing / IT skills -- Microsoft / EXCEL etc.
* Ability to undertake scheduling, data handling, e-mail, faxing, photocopying, document filing systems (manual and electronic).
* Excellent verbal communication / negotiating skills to include face to face and telephone skills. To resolve sensitive and non-routine issues.
* Ability to deal with conflicting demands
* Excellent organisational / co-ordination / work prioritisation skills.
* Excellent English language skills grammar, spelling).
* Excellent telephone skills / manner
* Articulate - required to liaise effectively with all staff groups and departments e.g. Consultants, nursing staff, clerical / clinical support staff, managers, sponsors etc.
* Able to respond professionally on behalf of the department.
* Demonstrates a sensitive attitude when responding to queries.
* Able to work alone or in a team, including occasional exposure to conflict.
* Able to work under pressure and to strict deadlines.
* Conscientious
* Honest and Reliable
* Demonstrates flexibility
Desirable
* Fully conversant with patient confidentiality.
* Good working knowledge of electronic systems within RD&I
* Ability to use own initiative
Disclosure and Barring Service Check: This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Mindelsohn Way
Birmingham
West Midlands
B15 2TH
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