Nursing Clinical Research Operations Lead

Nursing Clinical Research Operations Lead – Ellesmere Port & Agile

The person for this role needs to have experience in clinical trials but also needs to be comfortable with managing a team and looking after them which could include rota planning etc. They would like this person to live within a commutable distance to their head office, this role is more suited to a hybrid approach so they can work closely as a team. The head office in Ellesmere Port, and they would probably be expected to come in once or twice a week.

About the Role

Reporting to the Head of Clinical Operations you will be an integral member of the Healthcare Clinical Operations Team. You will assist the Head of Clinical Operations in the oversight of all clinical research projects, and lead on the management of clinical operations activity including staffing, delivery and managing the team of regional staff who will provide clinical oversight to the community research unit teams. You will be responsible for ensuring that clinical operations run smoothly to facilitate delivery to time and target across the portfolio. You will ensure that sites are delivering clinical research at a high quality and within a safe clinical research environment, manage clinical operations including nursing and research practitioner activities related to clinical trials, from initiation to close out according to ICH-GCP guidelines and regulatory requirements. This includes the safe, quality and patient-centred care of all of the research participants. You will also ensure commercial success through the successful recruitment and delivery of clinical trials by providing professional leadership to all direct reports and being responsible for the training, professional development, and supervision of your team. Be involved in developing systems and processes, and maintain an agile, competent, flexible research delivery team. You will develop excellent relationships across the different divisions within the organisation as well as all client contacts. You will be involved in reviewing and assessing the feasibility of pipeline studies and from that building on the wider client contact base.

Responsibilities

• Work in collaboration with cross-functional teams within to ensure timelines, KPIs, budgets and quality standards are met.
• Overseeing and managing day-to-day clinical operations, ensuring the effective delivery of clinical research projects to time and target and in accordance with study protocols, ICH-GCP, and applicable regulatory requirements.
• Responsible for maintaining high-quality standards across the department as set out in, SOPs, departmental objectives, and KPIs.
• Build, manage, lead and motivate an integrated, inclusive and flexible team, ensuring that people with the right range of skills and experience are recruited and retained, and that their skills and professional capabilities are maximised.
• Ensure appropriate onboarding of employees and provide training and support for all direct reports to ensure no knowledge gaps within the role are present.
• Support and oversee study set-up, study activities throughout the study duration and close out activities.
• Develop contingency plans and problem-solving strategies to address identified risks.
• Provide support and oversee action plans to address any areas of concern to create a quality and continuous development culture.
• Provide effective direction, leadership, and development of the clinical team and portfolio in support of the business.
• Promote and nurture a professional, welcoming, and pleasant environment for staff and participants to ensure effective team working.
• Manage administrative aspects of Line Management (Timesheets, expenses, performance reviews, etc.) of direct line reports.
• Contribute to SOP update and process improvements for the Clinical Operations Department and across the business as required.
• Facilitate and ensure effective communication, by participation in regular clinical team, multidisciplinary, project strategy, feasibility, and core study meetings.
• Enthusiasm to provide recommendations to help develop the Clinical Trials division and support the organisations Business Development Team to review research protocols and assess feasibility of new studies.
• Attend pre-study site selection visits, site initiation visits for any new study and keep up to date with any changes with study protocols.
• Identify, develop, coordinate, and deliver training, complete competency checks and education requirements for clinical team and others within the organisation as required.
• Contribute to working groups, initiatives, training and other commitments to support the growth of EMS Healthcare.
• Ability to visit Research Units, attend client meetings and travel throughout the UK.
• To support and participate in internal and external audits and regulatory inspections.

Qualifications

• NMC Registered Nurse
• A scientific degree, post graduate qualification or equivalent
• Good Clinical Practice Training
• Good working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical trials research.

Required Skills

• Substantial Experience as a Senior Clinical Research Lead with a minimum of 5 years working in a clinical research setting
• Strong leadership skills and a proven history of leading teams.
• Experience of staff management and development, clinical supervision and monitoring
• Experience of delegating responsibilities and prioritising workload
• Wide ranging experience in the conduct of clinical trials, including commercial trials
• Experience of working on clinical trials involving ‘Clinical Trials of Investigational Products (CTIMPs).
• Ability to monitor the quality of own and others work
• Experience of audits and regulatory inspections
• Experience of developing and implementing policies and procedures
• Ability to deal with conflict situations and experience of handling clinical incidents and complaints.
• Understanding and rising to the challenges in research delivery (including non-traditional research settings)
• Experience in Clinical Procurement and Vendor
• Excellent IT skills and proficient in using Microsoft Office.
• Excellent communication and presentation skills
• Ability to establish/maintain good relationships with sites/colleagues/clients
• Ability to make decisions independently / Strong problem-solving skills
• Self-motivation to research and understand the healthcare sector and NHS markets.
• A flexible approach to work

Preferred Skills

• Full UK residency and hold a valid driving license and have suitable transport provisions (public transport is not recommended due to location of offices)
• Able to travel throughout the UK and Overseas if required

Pay range and compensation package

Up to £65k per annum