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Detailed job description and main responsibilities

.     To undertake audits in line with the CRD rolling audit program. 

To undertake monitoring of studies and trial documentation.  To liaise with CRD research delivery staff and the wider trust, e.g. laboratory managers & Consultants, to ensure appropriate QA processes are implemented and adhered to.

2.     To liaise with Research Governance Manager to review critical and major findings resulting from internal/external inspections and to produce and implement CAPA reports

3.     To assist with the review and closure of CAPA reports

4.     To provide oral and written reports on activities to the Research Governance manager in line with overall responsibilities.

5.     To undertake relevant training. To perform any other duties required by Research Governance Manager 

Communication and Relationships

• Provide written, verbal and presentation updates and reports on a regular basis with CRD & CRF Operational team including senior medical staff, senior managers, nursing and service support staff such as pharmacy, laboratory, medical records.
• Liaises with external sponsors of trials
• Liaise with colleagues in RLBUHT Clinical Research Unit as required to support the joint Alder Hey/RLBUHT CRF strategy
• Confident in their ability to cascade clear, concise information in a timely manner

Analytical and Judgemental skills

• Identify, analyse and extract relevant data to assist in completion of monitoring reports

Planning and Organisational skills

• A high degree of QA & organisational skills required to ensure that correct procedures are followed in terms of clinical trials and that trial procedures are followed as per protocol
• High degree of organisational skills required to set up and maintain to support the Research Governance and Quality Assurance manager in embedding and delivery of QA process for clinical research

Physical Dexterity

·       Keyboard skills

Physical requirement for prolonged periods of concentration when cross referencing information and data

·       Frequent need to carry cumbersome trial files from clinical areas and within the offices

Policy and Service Development

·       Requirement to keep up to date with policy developments pertaining to QA and support implementation where necessary e.g. ICH GCP

·       To provide information regarding the performance of the CRF/CRD vs QA metrics across the  portfolio

Education and Training

·       To act as a QA resource for CRD/CRF staff and others involved in research studies within the trust

·       To maintain an awareness of current advances in QA clinical research

·       To continue professional development and attend training and meetings as required. Attend regular updates and feedback to multi-disciplinary team on developments in regulatory guidelines pertaining to QA for clinical research

·       Attend annual UKCRF conference if required

Research and Development

·       As a member of the multi-disciplinary team there will be involvement in the entire process of supporting clinical trials and other research studies.

Other

·       To understand and adhere to local Trust policies and procedures

·       The post holder has responsibility for safety as outlined in the hospital’s policy and Health and Safety Work Act 1974

·       To maintain confidentiality at all times