The HRB CRF-UCC Clinical Operations team consists of experienced clinical research professionals who work individually and as part of a multidisciplinary team in delivering high quality research to target, on time and within budget. The Clinical Operations team is made of a dedicated team of:

• Site Management and Operations Manager
• Clinical Research Nurse Manager II
• Research nurses
• Clinical Trials Physician
• Research Assistants
• Feasibility Coordinator
• Data Manager
• The Trials Set-up Co-Ordinator

The Site Management & Operations Manager

The Site Management and Operations Manager acts as the functional lead for the trial conduct portfolio of the CRF-UCC, with responsibility for the assessment, selection, set-up and delivery of studies and trials, ensuring consistency with the CRF-UCC quality plan, study contracts and budgets and in compliance with applicable regulations, controlled documents and ICH-GCP Guidelines. The Site Management and Operations Manager assists in feasibility assessments, oversees the conduct and progress of industry sponsored trials and the work schedule of staff working within the portfolio.

The Clinical Research Nurse Manager II

The Clinical Research Nurse Manager II takes a leading role in planning, coordinating and completing academic and sponsor led clinical trial protocols and supervises the work schedule of staff working on these projects.

Clinical Research Nurses

CRF-UCC research nurses provide high quality nursing services with a specialty focus on the care of research participants. The nurses collaborate and liaise effectively with Principal Investigators, Sponsors, affiliated research staff and external vendors in ensuring that protocol procedures are implemented with meticulous attention to ICH GCP, CRF-C SOPS and CRF-UCC working procedures.

Responsibilities:

In addition to providing and coordinating clinical care, clinical research nurses have a central role in:

• Study Initiation
• Informed consent process
• Protocol implementation
• Study conduct and coordination
• Patient recruitment and retention
• Randomisation procedures
• IMP management
• Assuring participant safety
• Adverse event reporting
• Follow up procedures
• Completion and maintenance of study documents
• Data entry and correction
• Maintenance of Investigator Site Files
• Liaison with investigator/research team/clinical staff/ monitors/sponsors/institutions
• Education of patients, colleagues

Clinical Research Assistants (CRA) Support

Our team of Clinical Research Assistants (CRA) work under the supervision of the Research Nurses and Principal Investigators. They are a flexible delivery team who are able to assist with data collection and data management, as well as providing clinical and recruitment support.

Feasibility Officer

The Feasibility Officer works on study set-up and feasibility as part of the CRCI National Feasibility Working Group. This involves managing an excel database of all studies and feasibility requests received by the CRF-UCC, logging study information, identifying potential Principal Investigators (PIs), meeting with PIs and providing support during the initiation and set-up phase of a trial.

CRF Data Manager

The CRF Data Manager maintains a web-based resource management system for clinical research studies (CRF Manager) in the CRF-UCC.

The Trial Set-up Co-ordinator

The Trial Set-up Co-Ordinator (Contracts) role is to ensure consistent management of contracts. This generally includes oversight of the contract management process, as well as development of specific standards, contract negotiations and document management. The Trial Set-up Co-Ordinator (Contracts) role in the contract development process requires close collaboration with various departments, including clinical operations, project management, business operations and finance.