Clerkenwell Health is an innovative and leading Research Organisation specialising in the delivery of scientifically grounded Clinical Trials using its collaborative Contract Research Organisation, extensive Site Network, and leading Therapy Development Programme. Clerkenwell Heath specialises in the supporting the Mental Health and CNS space with a focus on Psychedelic drug development.

The postholder will undertake responsibility for the overall supervision and coordination of the clinical research activities on site from potential study identification, feasibility assessments all the way through close out and archiving.

This post also has potential site management role where the post holder will also be asked to participate and undertake roles of site management activities such as coordinating vendor management, patient recruitment coordination, site budget and costing, planning and implementation of site fit out work for potential new sites to be built.

The role requires extensive knowledge and experience in clinical research and managing high level research activities for trial set up. This role will also require to engage in internal and external audits and promote compliance with Good Clinical Practice guidelines in all undertakings and most of all act as advocate for patients, site team and other stakeholders.

Main Duties and Accountabilities

Overview

• Undertake nursing activities relating to clinical trials from the start-up of a trial to the close out, working to ICH/GCP guidelines.
• Review research protocols, identify and coordinate training and education requirements for clinical reports.
• Ensure the commercial success of the site by contributing to the recruitment and retention of patients into trials.
• Screening and randomisation of potential study participants.
• Conducting informed consent discussions and taking informed consent.
• Completing study procedures such as phlebotomy, vital signs and ECG and reviewing medical histories.
• Administering medication as needed.
• Scheduling trial visits and tracking enrolled trial participants.
• Completing and organising regulatory documents.
• Communicating with the Sponsor, regulators and third party vendors.
• Performing all coordinator-mediated tasks, per individual protocols,
• Drug accountability and reconciliation.
• Processing and packaging specimens, per guidelines.

Clinical Trial Management (CTIMPs and Non-CTIMPs)

• Obtain informed consent from participants for CTIMP and non-CTIMP studies as delegated by Principal Investigator (PI) and within parameters of the protocol.
• Support participants considering their participation with the decision-making process, ensuring that their information needs are met sensitively and that they have a full understanding of the study, its requirements and their rights as participants.
• To ensure all adverse events are reported in line with the protocol adverse events reporting policy.
• Facilitate and maintain (written and verbal) communication between the PI, research and clinical teams in ensuring that the study protocol is correctly implemented, and research governance standards are met and maintained.
• Ensuring that all equipment used in the trial is appropriately calibrated and that supporting documentation is retained.
• Perform all visits, observations, and clinical procedures such as monitoring vital signs, body measurements, height and weight, ECGs, venepuncture, cannulation, drug administration with the participants in accordance with the procedures and schedule of the study protocol.
• Undertake laboratory work as per study protocols, including processing, packaging, storing and transportation of samples.
• Provide ongoing support to patients and volunteers with regards to their trial participation.
• Ensure that all clinical trial databases and logs are maintained including updating patient recruitment data on EDGE, our Local Performance Management System, on a weekly basis.
• Ensure protocol amendments are incorporated into research practice in a timely manner.
• Work within the scope of research guidelines, ethical principles and protocols, whilst adhering to organisational policies and procedures.
• Adhere to the confidentiality of patient information at all times, in accordance with the Data Protection Act, GDPR and Caldicott regulations.

General Clinical Duties

• Support senior colleagues in assessing, planning and implementing high quality care, and evaluating care options for patients in the clinical area, in line with the Clerkenwell values and objectives.
• Ensure the safe custody, maintenance and administration of medication, in accordance with established Clerkenwell policies.
• Promote and maintain a safe therapeutic environment for patients, their families and staff, according to national and local Infection Control guidelines, Health & Safety legislation and Clerkenwell policies and objectives.
• Provide sound evidence based clinical advice as required to staff and patients.
• Maintain a good understanding and implementation of clinical escalation procedures as required.
• Understand the Clerkenwell clinical governance framework and participate in the promoting and safeguarding of high standards of care, through effective risk management & governance, and adherence to the Clerkenwell values.
• Ensure that the team promote, ensure and adhere to the Clerkenwell safeguarding polices.
• Undertake effective multi professionally work with colleagues to deliver care.
• Monitor quality of standards of care in line with CQC requirements and Clerkenwell and Divisional objectives.
• Facilitate a high quality patient experience.
• Maintain a safe working environment ensuring equipment is safe and used in line with Clerkenwell policy and values.
• Promote and maintain patient safety at all times including proactively implementing falls prevention.
• Support with the detection, management and prevention of safeguarding issues.
• Keep up to date with current professional developments within the area of practice and disseminate to relevant staff members where appropriate.

Clinical Trial Set Up (CTIMPs and Non-CTIMPs)

• Liaise with the Sales, Science and Clinical Operations functional leads to identify trials in the pipeline.
• Contribute to the assessment of trial protocols, safety, regulatory and logistical issues in the running of the trial.
• Contribute to expressions of interest (EOIs) and trial feasibility meetings.
• Liaise with the SCTM and CTA to ensure all trials have the necessary regulatory and local site approval confirmation prior to commencement.
• Ensure compilation and maintenance of all site files in accordance with ICH-GCP.
• Assist with the set-up of studies and attend Site Initiation Visits.

Study Close Out

• Ensure all data clarification issues are resolved quickly.
• Assist with the archiving of study related documentation in line with the Trial Agreement and ICH-GCP.

Resource Management

• Supporting senior colleagues in ensuring research delivery within capacity.
• Shared responsibility for the safe use, maintenance and storage of computers, photocopiers and other office equipment.
• Contributing to effective stock control/maintenance.
• Managing the physical resources required to undertake research activity including monitoring those resources is fit for purpose, for example: within manufactures date and / or calibrated and that they are used accurately

Administrative Duties

• Supporting the CTA and SCTM in the maintenance of investigator site files and working files.
• Completing Case Report Forms (CRFs) including eCRFs with a high degree of accuracy.
• Setting up and maintaining study trackers.
• Implementing study amendments.
• Locating and tracking of medical records.
• Managing and participating in monitoring visits.
• Overseeing filing of research material such as laboratory and imaging reporting.
• Completing annual monitoring study reports.

Qualifications

Essential:

• Licensed Registered Nurse.
• Formal training in Good Clinical Practice (GCP).
• Extensive experience in Trial delivery in a clinical Research Facility.

Skills and Understanding

Essential:

• Extensive knowledge, skills and experience of Clinical Trial Delivery on Site Operations, Management of IMP.
• Experience of successful coordination, set up and delivery of multiple studies in a Clinical Research Facility.
• Experience in line management of junior staff.
• Exemplary Leadership Skills.
• In-depth knowledge of the principles of GCP, the EU Clinical Trials Directive and related UK Clinical Trials regulations, and the UK Policy Framework for Health and Social Care Research.

Prior Experience

Essential:

• Significant experience in the management of clinical trials, including Clinical Trials of Investigational Products (CTIMPs) at trial initiation and delivery level and of working according to Good Clinical Practice (GCP) the international ethical, scientific and practical standards to which all clinical research is conducted.
• Experience of leading clinical study team as study coordinator and exemplary communication amongst team members in including ensuring adherence of PI oversight.
• Significant experience in coordination and partnership with CRAs and other external sponsor representative relevant to the study process.
• Significant experience in creation and review of site management and Clinical SOP in relation to site delivery work.
• Experience and proven ability of line managing and developing staff.
• Experience of leading multi-disciplinary meetings.

Behavioural Characteristics

Essential:

• Excellent written and verbal communication skills.
• Able to balance the pressures of research, clinical duties and administrative demands and competing deadlines.
• Able to form positive professional relationships and influence stakeholders at a senior level.
• Able to display exemplary leadership and motivation amongst the members of the team.
• Able to influence building strong relationships with CROs and Sponsors and other stake holders.
• Able to proactively assume responsibility and make decisions impacting the course of a clinical trial study.
• Commitment to ongoing organisational innovation that includes personal development and training of others.