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Research Governance Manager
| Dyddiad hysbysebu: | 27 Mehefin 2024 |
|---|---|
| Cyflog: | £43,000.00 i £50,000.00 bob blwyddyn |
| Gwybodaeth ychwanegol am y cyflog: | £43000.00 - £50000.00 a year |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 12 Gorffennaf 2024 |
| Lleoliad: | Blackpool, FY3 7EN |
| Cwmni: | NHS Jobs |
| Math o swydd: | Parhaol |
| Cyfeirnod swydd: | A0881-24-0001 |
Crynodeb
JOB TITLE : Research Governance Manager SALARY : 43-50 K dependent on experience LOCATION :Fylde Coast Clinical Research, Layton Medical Centre, 200 Kingscote Drive, Blackpool FY3 7EN RESPONSIBLE TO Chief Operating Officer, FCCR ACCOUNTABLE TO Directors, FCCR JOB PURPOSE The Research Governance Manager will be responsible for ensuring the continued high quality conduct of clinical research at Fylde Coast Clinical Research through the management of research governance, compliance, data integrity and quality of all trials across the organisation, working within legislative requirements. The postholder will be expected to ensure that all research carried out complies with the UK Policy Framework for Health & Social Care Research, ICH GCP standards and best practice, including MHRA guidance and study Sponsor requirements. In addition they will be expected to: Ensure organisation wide compliance with research policies and procedures Support the development of new and evolve existing research Standard Operating Procedures for FCCR Work closely with the FCCR leadership team to support the costing and contracting process in line with FCCR's and national expectations Ensure that research active staff within FCCR are advised, and monitored according to research governance & quality assurance requirements Support the training of research staff, co-ordinate and advise on research governance activities Ensure confidential research documentation are collated, recorded, and filed according to appropriate policies and standards. Support and enhance our external Sponsor relationships to ensure a continued robust pipeline of clinical trials for our research participants Prepare when required understandable complex internal and external reports Liaise with research participants when required to ensure we are maximising their research participant experience here at FCCR The postholder will work collaboratively with other research colleagues locally and nationally when required Any other duties commensurate with the grade and as required by the leadership team of FCCR Key Responsibilities Start-Up Tasks: - Coordinate and manage the initiation of new clinical trials. - Ensure all necessary regulatory documents and approvals are obtained. - Develop and maintain trial-specific governance documentation. - Conduct site feasibility assessments and selection processes. - Liaise with investigators, sponsors, and regulatory bodies to ensure smooth trial initiation. Data Management: - Oversee the development and maintenance of data management plans. - Ensure accurate and timely data collection, entry, and verification. - Implement data quality control procedures and resolve data discrepancies. - Ensure compliance with Good Clinical Practice (GCP) and other regulatory standards. - Collaborate with data management teams to streamline processes and improve data integrity. Oversight of Amendment Implementation: - Manage and oversee the implementation of protocol amendments. - Ensure all amendments are communicated effectively to relevant stakeholders. - Update trial documentation and databases to reflect amendments. - Monitor and ensure compliance with amended protocols. - Conduct training sessions for clinical trial staff on protocol changes. General Governance and Compliance: - Develop and implement research governance frameworks and policies. - Conduct regular audits and inspections to ensure compliance with regulatory requirements. - Prepare and present reports on clinical trial governance and compliance. - Address and resolve any governance-related issues that arise during trials within appropriate timelines - Stay up-to-date with changes in regulatory requirements and industry best practices.