Band 8A - Regulatory Compliance Manager
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Our trust has around 10,000 staff serving 1.6 million patients. It comprises Barnet Hospital, Chase Farm Hospital, the Royal Free Hospital and more than 30 services in the community. This larger scale organisation provides an unprecedented opportunity for us to continue our pioneering work, particularly in finding ways to deliver even better care to our patients.
Our mission is to deliver world class care and expertise in our clinical services, underpinned by world class teaching and research and we will continue to measure our progress against our five governing objectives: excellent outcomes, excellent patient and staff experience, excellent value for taxpayers' money, being safe and meeting our external duties, and building a strong organisation.
Everyone is welcome at Royal Free London NHS Foundation Trust. We're proud of our diversity and we continue to undertake new initiatives to advance equality for LGBT+, BME, gender equality, staff carers and people with disabilities and lived experiences to promote good relations and understanding between our staff.
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Job overview
An exciting opportunity has arisen for an exceptional individual to be appointed as the Research Compliance Manager within the growing R&D Office at the Royal Free Hospital.
The successful applicant will have excellent interpersonal and written communication skills, be practical, methodical and organised.
Previous applicants need not apply.
Main duties of the job
The main duties of this job will enable the Trust to Sponsor regulated studies underpins the Trust tripartite ambition to deliver leading healthcare treatment, ground- breaking clinical research and teaching excellence and in line with the 5-year R&D strategy.
The role will enable the Trust to sponsor regulated studies at RFL which aims to maximise opportunities for the organisation and ensure reputational benefits. The job will build on RFL's international reputation for research and expand our capacity to conduct complex and higher risk experimental research. This enhanced research infrastructure is expected to attract the next generation of aspiring academics and establish RFL as one of the UK's leading centres for clinical and translational research.
Working for our organisation
The R&D Office operates agile working for staff members and places the Trust's values at the heart of how we conduct our relationships with our staff, patients and stakeholders.
Detailed job description and main responsibilities
The post holder will have a key role in co-ordinating working practices and policy implementation, ensuring the Trust is compliant with internal Standard Operating Procedures (SOPs), polices and external regulatory frameworks at all times.
The post holder will coordinate all necessary preparation for external audit and regulatory inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) on RFL Sponsored regulated studies.
The post holder will also be one of the nominated delegated research archivists for the department and will be required to ensure that this process is performed according to regulatory standards and trust R&D processes for all Sponsored regulated trials conducted and will undertake routine auditing of these systems and processes.
The post holder may also be expected to spend a proportion of their time assisting with trial coordination, and thus may be required to take full responsibility for the management and coordination of several clinical trials, based on workload and business needs.
For the full job description and responsibilities please refer to the PS and JD.
Person specification
Knowledge and Qualifications
Essential criteria
- First degree or equivalent in clinical or life science related subject
- Evidence of further education including post graduate certificate/diploma/CPD in clinical research
- Good knowledge of research frameworks and legal acts underpinning these
- Knowledge of local, national and international developments in clinical research policy
Desirable criteria
- Formal training/ certification in Quality Management and/or monitoring clinical trials
QMS and Experience
Essential criteria
- Significant experience of undertaking, co-ordinating or managing clinical research
- Experience of developing and implementing QA procedures for regulated studies in a clinical research environment.
- Experience of undergoing an inspection and audit by an external authority
Desirable criteria
- Experience of managing QA systems for clinical trials in Phases I, II and Ill
- Experience of providing training in GCP/GLP
- Experience of working in the NHS
Skills and Abilities
Essential criteria
- Excellent communication skills
- Ability to interpret complex information to facilitate change
- Confident in making autonomous professional decisions relating to QA
- Good negotiating skills and the ability to influence others at all levels to initiate change
- Covid-19 Vaccination
Getting vaccinated, and getting a booster, remains the best defence against COVID-19.
We encourage and support staff to get COVID-19 vaccine and a booster dose as and when they are eligible. - AT* - Apprenticeship Training. Where AT* is entered next to the job title indicates that this vacancy is for an apprenticeship role.
- By applying for this role, you accept if successful, that your personal data may be transferred from the Trust to another NHS organisation where your employment transfers within the NHS. This is in accordance with the streamlining programme which aims at saving you time and improving efficiencies within the NHS when your employment transfers. Therefore we require you to complete your stat and Man e-learning modules prior to joining our organisation.
- If you are an EU/EEA citizen who does not have EU Settlement or Pre-Settled status, you will require a visa to work in the UK.
- Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. Before submitting your application and to avoid disappointment please check that you are eligible under the UKVI points based system.
- If you are offered a role with one of the NLPSS partner trusts, as part of pre-employment checks your identity and right to work documentation will be verified remotely (in most circumstances), using a certified identity verification service provider TrustID. You will be asked to capture an image of the relevant documents as well as a "selfie" using your smartphone/tablet (if available) for facial matching. TrustID will also perform a digital address check using Trunarrative and Equifax, which is a soft check and does not leave a footprint on your credit rating. For more information, visit www.trustid.co.uk
- The Trust uses electronic new starter forms on Trac to collect personal details. Information collected is securely stored and used to set up the employee record on the ESR HR system.
- The Trust will request a DBS (CRB) if post involves regulated activities. The Trust is compliant with the Disclosure and Barring Service Codes of practice and the Rehabilitation of offenders act.
- By applying for this post you are agreeing to Royal Free London NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job, information will also be transferred into the national NHS Electronic Staff Records system.
- Please be aware of scams - unless specified above, we will only communicate with you via @recruit.trac.jobs or nhs.net e-mails and we will never ask you for any payments.
Applications are welcome from people wishing to job share or work flexible patterns. We are committed to equal opportunities.
Please note:
- Due to the high number of applications that are received for some posts we may close this vacancy before the advertised closing date. Therefore please apply for this post as soon as you can, if you are interested and you meet the requirements of the Person Specification
- Only those candidates who clearly demonstrate how they meet the person specification will be shortlisted for this job.
- Interview arrangements will be communicated via email so please check your email regularly following the closing date.
Please be advised that due to exceptionally high demand, all Royal Free accommodation is at full capacity and waiting lists are being held. Average waiting times are 12 months. Please do not rely on Trust accommodation when you commence your role and ensure you investigate alternative accommodation for your arrival.
Employer certification / accreditation badges
Documents to download
- RCM Job Descriptopn (PDF, 210.6KB)
- RCM Person Specification (PDF, 64.9KB)
- Functional Requirements (PDF, 110.1KB)
- Corporate, Admin & Clerical, Other - benefits, about RFL, values and governing objectives (PDF, 935.8KB)