Trinity College Dublin (Trinity) has a policy to support clinical research as a Sponsor of clinical trial. As part of the implementation of Sponsorship in Trinity, the role of Head of Clinical Sponsorship Oversight (HCSO) is being introduced to provide oversight of clinical trial conduct and review and assess Trinity’s high risk clinical research study portfolio. The HCSO will work with Dean and Vice-President of Research, Trinity Research & Innovation (TR&I) and various College entities that that engage in clinical trials and clinical research, including the Wellcome – HRB Clinical Research Facility located at St James’s Hospital (CRF); the Trinity Cancer Institute and other areas, to operationalise Sponsorship. The operational management team supporting the HCSO will include a Sponsorship Quality and Regulatory Affairs Manager (QRAM-S) who will support the Sponsorship services within the university.
The Head of Clinical Sponsorship Oversight (HCSO) is responsible for ensuring that Trinity Sponsored trials are appropriately risk-assessed, operationalised and managed throughout lifecycle along with liaising with TR&I with respect to high risk clinical research. HCSO will have responsibility for oversight of clinical trials of investigational medicinal products and clinical investigations of medical devices (‘Trials’) Sponsored by Trinity. The HCSO will provide a review and risk assessment of Trinity’s high risk clinical research studies to identify studies that Trinity needs to manage. The HCSO will be responsible for confirming the adequacy of Trinity indemnity cover and risk management processes for safe conduct of clinical trials and will liaise with the Contracts Office and Estate and Facilities Department to confirm that appropriate agreements and indemnity are in place for Trinity Sponsored trials. The HCSO will be based at the university campus will report to the Dean of Research and the Head of Research Contracts.
Post Status: 35 hours per week Full time. 36 Month Fixed term contract
Salary: This appointment will be made on the Administrative Officer 1 Salary Scale, Full scale, (€60,692- €96,100 per annum) at a point in line with current Government pay policy. [
•To review applications for Trial Sponsorship and clinical research projects in terms of safety, benefit / risk, financing and appropriate trial management structures and to make recommendations to the Dean of Research on whether the study is suitable and feasible for Sponsorship.
• To review high risk clinical research studies undertaken by Trinity, this will include identifying studies that require regulatory approval and Sponsorship and notifying such studies to the Contracts Office and Dean of Research.
• Implementation of risk management plans and governance framework for Trinity Sponsored Trials.
• Review and approval of Trial protocols and Trial documentation to ensure the integrity and scientific validity of the study and the safety of the participants.
• To facilitate the establishment of a Trial Steering Committee and Data and Safety Monitoring Board (DSMB)/ safety review board for Trinity Sponsored Trials & and clinical research projects.
Bachelor’s degree or an advanced degree in a clinical or life sciences related discipline or profession.
Knowledge and Experience
• A minimum of 5 years’ experience in management and oversight of regulated clinical studies with leadership or project management role.
• Strong knowledge of the regulatory landscape and legislation governing clinical trials of drugs and medical devices in Ireland and in the E.U.
• Knowledge of sponsor responsibilities as defined by Good Clinical Practice guidelines.
• Experience interpreting legislation relating to clinical research.
• Experience ensuring performance and governance of quality management systems, regulatory affairs and risk assessments.
• Experience liaising with competent authorities and research ethics committees.
How to apply:
In order to assist the selection process, applicants should submit a Curriculum Vitae and a Cover Letter (1x A4 page) which specificaly addresses the points as stated in the job description, before the closing date.
Applicants who do not meet the application requirements will not be considered at the short list stage. Applications must be submitted by the closing date specified through eRecruitment. Any Applications which are still in progress at the closing time on the specified closing date will be cancelled automatically by the system.
Closing date: 12 noon 1st August 2022
At Trinity, we are committed to equality, diversity, and inclusion. Trinity welcomes applications from all individuals, including those who may have had non-traditional career paths, those who have taken time out for reasons including family or caring responsibilities, and applicants with disabilities.