Overview
The successful candidate will have strong communication skills, be adaptable to a fast-paced and evolving environment, and bring a proactive, solutions-focused attitude to their work. The post holder will co-ordinate research trials/studies under the leadership and direction of the Principal Investigator and/or Matron and Business Manager. The post holder will liaise with researchers, sponsors, data teams, university representatives, as well as Principal investigators, research staff and the General Manager for ophthalmology. The post holder will deputise for the Business Manager in their absence. With mentorship from the Business Team, lead and facilitate the large studies/projects to time and target.
Responsibilities
* Direct responsibility for the day to day registration and effective management of all non-commercial and grant based research projects through the Clinical Eye Research Centre.
* Assess research costings and provide advice to Trust researchers on the setup and processing of research projects.
* Serve as part of the Business team as the point of contact for the sponsor, ensuring expectations are met while identifying and mitigating risks.
* Be responsible for long-term study projects, ensuring the accuracy and quality of regulatory data.
* Manage projects with support from Business Team members and the Chief Investigator/Principal Investigators; deputise for the Business Manager in their absence.
* With mentorship from the Business Team, lead and facilitate large studies/projects to time and target; complete all feasibilities and expressions of interest forms covering all research PIs.
* Ensure effective cross-functional teamwork among study team members including both internal and external ancillary services.
* Manage and track project resource needs and contribute to contingency planning for key resources; create required plans utilizing appropriate planning software.
* Implement and monitor progress against project plans and revise as necessary; monitor schedule and scope to ensure both remain on track; implement and follow pre-approved procedures for any deviations.
* Oversee/complete accurate and timely Ethics/R&D Submissions in conjunction with the Lead Nurse/PI.
* Present at external and/or internal meetings, with support from a more senior manager or Principal Investigator as needed.
* Assist in ensuring that all staff allocated to assigned projects adhere to professional SOPs and specific GCP and ICH standards.
* Review proposals and budgets as required; follow defined study/trial issue escalation process.
* Monitor and control the risk plan with support from more senior management positions and the Principal Investigator; provide on-going oversight to ensure mitigation plans are in place and working; escalate newly identified risks to stakeholders.
* Meet financial performance targets for the assigned projects and proactively identify out of scope activities and execute necessary work scope change orders.
* Collaborate with the RD&I Business team to initiate monthly invoicing on larger assigned projects; ensure monitoring reports and visits are completed in a timely manner and escalate issues as needed.
* Establish working relationships with clients/sponsors to increase client satisfaction and potential for repeat business; track study/trial metrics; conduct internal review meetings as needed; lead meetings as appropriate depending on project size and scope.
* Perform other duties as assigned by management.
Qualifications
* Graduate with Hons Degree/equivalent knowledge, preferably in a science or clinical area.
* Relevant clinical research experience in a pharmaceutical company/CRO including study management and/or project management experience (essential).
* Demonstrable experience in managing or coordination of clinical studies.
* Experience in effective use of Microsoft Office package including Microsoft Project or other planning software.
* Desirable criteria:
o Experience of liaison with staff at all levels in the NHS, Universities and Industry.
o Leadership/management experience.
o Experience of being a client/sponsors primary point of contact.
o Experience in Phase I Clinical Trials; knowledge of the principles & practice of clinical research and/or clinical trials.
o Knowledge of ethical and quality standards applicable to clinical trials, including EU Directive ICH/GCP requirements.
o Demonstrate knowledge of NHS Research Governance.
o Understanding of the drug development process.
o Ability to understand and work with financial information.
o Working knowledge of study/trial management processes; good communication, presentational, training and interpersonal skills.
o Ability to use a personal computer.
o Skills in administration & research management.
o Ability to meet tight deadlines and cope in a highly demanding environment.
o Ability to work independently and prioritise/own workload and communicate effectively with all members of the multidisciplinary team.
o Ability to liaise with clients/sponsors in a professional manner.
o Good planning and organization skills.
o Skills in handling and management of computerised data.
o Skills required to evaluate and assist in developing new protocols; skills in the analysis and interpretation of data; meticulous attention to detail and a high standard of accuracy.
Organization and Context
The Clinical Eye Research Centre within Ophthalmology at the Liverpool Foundation Trust is a purpose built unit facilitating Clinical Trials and studies in all aspects of Eye Research. The unit undertakes and delivers clinical trials/studies in patients and healthy volunteers for commercial, non-commercial and sub contract studies. This is an exciting opportunity to those with research background/knowledge to play a key role in a team working at the heart of ophthalmic research in the Liverpool City Region.
Notes and Compliance
Liverpool University Hospitals NHS Foundation Trust comprises Aintree University Hospital, Broadgreen Hospital & Royal Liverpool University Hospital. We are part of NHS University Hospitals of Liverpool Group. Note: Under current Home Office Immigration Rules we may be unable to offer right to work visa sponsorship for certain roles below certain salary thresholds. The Trust is committed to safeguarding and diversity policies. All staff must complete mandatory safeguarding training and adhere to safeguarding policies. If you have any personal requirements to participate in our recruitment process please contact Recruitment Services. New entrants to the NHS will commence on the first pay point of the relevant band.
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