The post-holder will be the PROTECT-UP Trial Manager.

The PROTECT-UP trial is a Heart Research UK-funded multicentre randomised clinical trial, assessing whether upgrading pacemakers from delivering RV pacing to more physiological methods delivers improved patient outcomes in patients who have an LV ejection fraction of 35-50% who experience a high degree of RV pacing.

They will have a leading role in planning, coordinating and ensuring delivery of the trial to time and to target, as part of a multidisciplinary team.

They will develop specialist knowledge of applicable regulations, as appropriate, and be able to provide regulatory and/or governance advice where required.

They will use strategic, tactical and operational management skills in the planning and execution of this landmark physiological pacing trial. They will have excellent communication and presentation skills, together with the ability to organise and motivate others.

They will have a pivotal role assisting in the management of this trial.

The post holder will establish good working relationship with all parties, including sites across the UK, industry partners and regulatory bodies.

This post will involve establishing recruitment, coordinating investigations and follow-up visits, collecting and documenting accurate data and ensuring quality control measures are in place.

The post holder will be expected to work with PIs to optimise patient recruitment at all sites and ensure the patient’s investigations and follow up visits adhere to the study protocol.

In addition, the post-holder will undertake study Sponsor activities, including preparation of study documents, maintaining the Trial Master Files, producing progress reports and convening study meetings.

Duties and responsibilities

Responsible for day to day running of PROTECT-UP trial including governance approvals, recruitment of patients.

• Prepare reports for submission to the Heart Research UK Charity (Funder)

• Be responsible for all coordination, administrative activities, and data management to ensure efficient running of the trials.

• Maintain the Trial Master File.

• Work together with other members of the trial-group to ensure that the electronic CRF / database is provided in a timely way and works efficiently

• Develop and implement comprehensive procedures for timely and clear reporting of trial status including progress and recruitment rates.

• Co-develop standard operating procedures (SOPs) for the initiation and coordination of the study.

• Set up new sites and conduct initiation visits as required.

• Plan and conduct site monitoring visits according to the monitoring plan and in line with the study risk assessment.

• Manage timely and efficient procedures for collection, entry and monitoring of study data.

• Monitor trial finances, reviewing expenditure against budget and ensure adherence to terms of all relevant contracts.

Essential requirements

Bachelor’s degree or equivalent in biomedical / scientific field

• Working knowledge of the current EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of GCP, GDPR, Data Protection Act and Research Governance Framework legislation and proven ability to apply these to the coordination of clinical trials

• Evidence of preparing regulatory and ethics submissions, writing/amending protocols, patient information sheets, case report forms (CRF) / electronic CRF, and other relevant trial management documentation

• Excellent relationships with hospital care and support staff and excellent relationships with patients

• Experience of working within the NHS or academic clinical research setting

Further information

The College is currently trialling a Work Location Framework until early 2023. Hybrid working may be considered for this role and the role holder may be expected to work 60% or more of their time onsite, with 40% the minimum time spent onsite. The opportunity for hybrid working will be discussed at interview.

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The College believes that the use of animals in research is vital to improve human and animal health and welfare. Animals may only be used in research programmes where their use is shown to be necessary for developing new treatments and making medical advances. Imperial is committed to ensuring that, in cases where this research is deemed essential, all animals in the College’s care are treated with full respect, and that all staff involved with this work show due consideration at every level.

http://www.imperial.ac.uk/research-and-innovation/about-imperial-research/research-integrity/animal-research/

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