Research Governance Manager

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, 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.

Person Specification

Qualifications

Essential

• Bachelors degree in Life Sciences, Clinical Research, or a related field; advanced degree preferred.
• Minimum of 2-5 years of experience in clinical trials, with a focus on research governance and compliance.
• ICH GCP Certification

Experience

Essential

• Strong knowledge of GCP, MHRA and other relevant regulatory guidelines.
• Significant understanding of commercial clinical research delivery.
• Excellent organisational, analytical, and problem-solving skills.
• Proficient in clinical trial management systems and electronic data capture (EDC) systems.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Detail-oriented with a commitment to maintaining high standards of quality and accuracy.
• Advocate for our research participants

Desirable

• Experience of research inspections and audits (external and regulatory authorities)

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

Employer name

Layton Medical Centre

Address

200 Kingscote Drive

Blackpool

FY3 7EN

Employer's website

https://www.laytonmedicalcentre.co.uk/ (Opens in a new tab)