Job summary
This is a unique and exciting opportunity for an enthusiastic and motivated individual to join the Research Team of Fylde Coast Clinical Research (FCCR), which is embedded within Layton Medical Centre, an NHS GP Practice in Blackpool.
Renowned as a national leader in recruitment to late Phase II/III clinical trials across a broad range of primary care specialties, you will be working in a fast paced environment with our research participants at the heart of everything we do. We are looking for an experienced, detail-driven individual.
TheResearch Governance Managerwill be a pivotal role and the postholder will be responsible for ensuring the continued high quality conduct of clinicalresearch at Fylde Coast Clinical Research through the management of researchgovernance, compliance, data integrity and quality of all trials across the organisation,working within legislative requirements. Interviews will be held on Tuesday 16th July 2024. If you wish to apply, please send a current CV and covering letter via email to
Main duties of the job
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 Sponsor requirements. The postholder will manage start-up tasks as well as ensuring data managementprocesses are robust and compliant, overseeing the complete lifecycle of a clinical trial. The ideal candidate will have a strong background inclinical trial operations, regulatory requirements, and data management.
The postholder will be expected to utilise administrative, analytical, financial,communication and interpersonal skills and have a proven aptitude for developingsystems and structures.
About us
For the right candidate you will work within a supportive, flexible environment and will be provided with training and development opportunities as well as access to NHS standard benefits including NHS Pension. You will become part of a dynamic team who continue to push the boundaries supporting the successful delivery of clinical research across the NHS in the UK.
We are an award-winning Research Site and notably in 2023 won the PharmaTimes Clinical Site Team of the Year Gold Award.
Job description
Job responsibilities
JOB TITLE : Research Governance Manager
SALARY : 43-50 K dependent on experience
LOCATION : Fylde Coast Clinical Research, Layton Medical Centre, 200 Kingscote Drive, BlackpoolFY3 7EN
RESPONSIBLE TO Chief Operating Officer, FCCR
ACCOUNTABLE TO Directors, FCCR
JOB PURPOSE
The Research Governance Manager will beresponsible for ensuring the continued high quality conduct of clinical researchat Fylde Coast Clinical Research through the management of research governance,compliance, data integrity and quality of all trials across the organisation, working withinlegislative requirements. The postholder will be expected to ensure that all research carried out complieswith the UK Policy Framework for Health & Social Care Research, ICH GCPstandards and best practice, including MHRA guidance and study Sponsor requirements. In addition they will be expected to:
1. Ensure organisation wide compliance with research policies and procedures
2. Support the development of new and evolveexisting research Standard Operating Procedures for FCCR
3. Work closely with the FCCR leadership team tosupport the costing and contracting process in line with FCCR's and nationalexpectations
4. Ensure that research active staff within FCCRare advised, and monitored according to research governance & qualityassurance requirements
5. Support the training of research staff, co-ordinateand advise on research governance activities
6. Ensure confidential research documentation arecollated, recorded, and filed according to appropriate policies and standards.
7. Support and enhance our external Sponsor relationships to ensure a continued robust pipelineof clinical trials for our research participants
8. Prepare when required understandable complexinternal and external reports
9. Liaise with research participants when required to ensure we are maximising their research participant experience here at FCCR
10. The postholder will work collaboratively withother research colleagues locally and nationally when required
11. Any other duties commensurate with the grade andas required by the leadership team of FCCR
Key Responsibilities
12. Start-Up Tasks:
- Coordinate and manage the initiation of newclinical trials.
- Ensure all necessary regulatory documents andapprovals are obtained.
- Develop and maintain trial-specificgovernance documentation.
- Conduct site feasibility assessments andselection processes.
- Liaise with investigators, sponsors, andregulatory bodies to ensure smooth trial initiation.
13. Data Management:
- Oversee the development and maintenance ofdata management plans.
- Ensure accurate and timely data collection,entry, and verification.
- Implement data quality control procedures andresolve data discrepancies.
- Ensure compliance with Good Clinical Practice(GCP) and other regulatory standards.
- Collaborate with data management teams tostreamline processes and improve data integrity.
14. Oversight of Amendment Implementation:
- Manage and oversee the implementation ofprotocol amendments.
- Ensure all amendments are communicatedeffectively to relevant stakeholders.
- Update trial documentation and databases toreflect amendments.
- Monitor and ensure compliance with amendedprotocols.
- Conduct training sessions for clinical trialstaff on protocol changes.
15. General Governance and Compliance:
- Develop and implement research governanceframeworks and policies.
- Conduct regular audits and inspections toensure compliance with regulatory requirements.
- Prepare and present reports on clinical trialgovernance and compliance.
- Address and resolve any governance-relatedissues that arise during trials within appropriate timelines
- Stay up-to-date with changes in regulatoryrequirements and industry best practices.
Person Specification
Qualifications
Essential
16. Bachelors degree in Life Sciences, Clinical Research, or a related field; advanced degree preferred.
17. Minimum of 2-5 years of experience in clinical trials, with a focus on research governance and compliance.
18. ICH GCP Certification
Experience
Essential
19. Strong knowledge of GCP, MHRA and other relevant regulatory guidelines.
20. Significant understanding of commercial clinical research delivery.
21. Excellent organisational, analytical, and problem-solving skills.
22. Proficient in clinical trial management systems and electronic data capture (EDC) systems.
23. Strong communication and interpersonal skills.
24. Ability to work independently and as part of a team.
25. Detail-oriented with a commitment to maintaining high standards of quality and accuracy.
26. Advocate for our research participants
Desirable
27. Experience of research inspections and audits (external and regulatory authorities)