Job Title: Study Feasibility and Activation Manager Department: RCSI Clinical Research Centre, Beaumont Reporting to: Professor Ger Curley, Director of Clinical Research Centre Location: RCSI Smurfit Building, Beaumont Hospital Contract/Duration: 0.4 FTE - Specified Purpose contract up to 17 months Remuneration: Up to €25,000 per annum Closing Date: 10th August 2025 RCSI is a community of academic, research, clinical and professional staff working collaboratively to lead the world to better health. Here, you will thrive in an innovative and inclusive atmosphere and your personal development and wellbeing will be supported. We invite you to join us to help deliver on our exciting mission "To educate, nurture and discover for the benefit of human health". We seek candidates whose experience to date has prepared them to contribute to our commitment to the "Race Equality Action Plan 2025-2029" at RCSI. Our students come from all walks of life and so do we. We hire great people from a wide variety of backgrounds. This makes our university stronger and ensures we hire the best talent. Innovating for a Healthier Future 2023-2027 is RCSI's new five-year strategic plan. Through it, RCSI will enhance human health by meeting the health workforce needs of society, creating the insights and inventions that drive health improvements, and working in partnership with patients and the public in support of better health and well-being for all. The strategy unites the RCSI community in supporting the UN Sustainable Development Goals - with a particular focus on Goal 3, which targets good health and well-being. For each of the last six years, RCSI has been positioned in the Top 300 of universities worldwide in the Times Higher World University Rankings. We are proud that RCSI ranks fifth in the world for "Good Health and Well-being" in the Times Higher Education #SDG #SDG Impact Rankings 2024. This reflects our commitment to supporting people of all ages to live healthy lives and our work to promote the concepts of well-being and positive health. In 2024, RCSI was delighted to be named one of the Sunday Times Best Places to Work in Ireland. At RCSI, our core values of Respect, Collaboration, Scholarship, and Innovation are at the heart of everything we do. We are committed to creating an inclusive and supportive environment where every colleague is valued and empowered to thrive. Our dedication to these values ensures that we foster a culture of mutual respect, open collaboration, continuous learning, and innovative thinking. Join us at RCSI, where your contributions will be recognised, and you will be part of a dynamic team making a real impact on global health. The Royal College of Surgeons in Ireland (RCSI) is a research intensive, world-leading international University exclusively focused on improving human health. The RCSI Clinical Research Centre (RCSI-CRC) was established in 2000 at Beaumont Hospital as the first purpose-built CRC in Ireland. Today, RCSI-CRC supports research in core clinical areas in Beaumont and Rotunda Hospitals, which serve as hubs for seven hospitals in RCSI Hospitals Group, including: 1. Respiratory and Critical Care Medicine - National Centre for Cystic Fibrosis, Alpha-1-Antitrypsin Deficiency. 2. Kidney disease - National Centre for Renal Transplantation, Renal Replacement Therapy, Rare Kidney Disease. 3. Clinical Neurosciences - National Neurosurgical Centre, National Pituitary Centre, National Lead for ENDO-ERN, Stroke/National Thrombectomy Service, National Epilepsy Surgery Service, Motor Neuron Disease 4. Gastroenterology - Centre for Inflammatory Bowel Disease and Advanced Endoscopy. 5. Maternal and Fetal Medicine - Host for HRB Mother and Baby Clinical Trials Network. 6. Haematology and Oncology - Regional/National centre for Breast Cancer, Primary Brain Tumours, Gastrointestinal Tumours, Myeloma/Lymphoma. The development of RCSI-CRC underpins the RCSI and Beaumont/Rotunda Hospital's tripartite ambition to educate, nurture and discover for the benefit of human health. The development of RCSI-CRC will build capacity and capability to deliver clinical trials in our core clinical areas, increase our research outputs and our recruitment to clinical trials. RCSI Clinical Research Centre (RCSI-CRC) Study Feasibility and Activation Manager RCSI-CRC works to improve patient access to clinical trials. We are seeking an exceptional individual to take on the role of CRC Study Feasibility and Activation Manager to deliver the study feasibility and Start-up programme at RCSI-CRC. Specifically, the duties of the post are: o The RCSI-CRC Study Feasibility and Activation Manager will be leading and rapidly conducting the site feasibility, hospital approval process and set-up phase of clinical trials in the CRC. o Guide the sponsor through the sites start up process to ensure a focused approach to timely study activation. This includes receiving a request, disseminating the study information to potential investigators, collating signed CDAs and study feasibility responses from investigators and engaging the ORI Pre-award Team and Industry Engagement supports in relation to same o Manage the feasibility assessment of the study and sites capacity, coordinate the legal agreement process and budget process, processing of the study application through the CRC and the hospitals approval process, liaise with the clinical team on their requirements to conduct the study and coordinate the activation of the study at the site o Coordinate and host feasibility meetings with sponsors and the relevant clinical team members until study greenlight o Review study protocols to determine the requirements for implementation of the study at the site. This includes hospital services, diagnostics, medication and equipment required by site or provided by the sponsor. o Liaise with relevant hospital departments for the provision of services or equipment for the study as required. o Liaise with sponsor on the provision of equipment they are providing for the study. o Gather and collate study start up documentation in preparation for study greenlight and activation such as CV's, GCP certs and training records etc. o Support the PI and the clinical team in the completion of documentation required for the feasibility and activation process, such as feasibility questionnaires, NREC site forms, CRC application form and sponsor forms. o Keep in regular contact with the PI and clinical team on the progress of study start up to prepare for timely activation and recruitment. o Track study activation timelines from first knowledge of the study in the CRC to green light activation. o Provide feasibility and activation metrics to the CRC management team as required. o Be responsible for collating and submitting the documentation required for hospital approval and follow hospitals approval process for study approval. o Inform study team and sponsor when hospital approval has been granted, and provide RCSI and the sponsor with copies of the signed documentation. o Act as the central point of communication about the study until activation o Act as a communication hub for clinical trials in RCSI-CRC. o Develop a local communication plan so that Beaumont Hospital consultants are aware of the RCSI CRC Feasibility Program at induction, research events and workshops. o Develop a database of research interested and/or active investigators in RCSI and Beaumont Hospital o Deliver local support and expertise on how to complete timely study feasibility assessments and study budget preparations. o Support nursing staff in study activation procedures and ensure timely activation of the site when requested by sponsor. o Use CRF Manager software to collate uniform data on Clinical Trials in RCSI-CRC o Keep records of studies worked on and feasibility and activation hours for the purposes of reporting o Work with a wide range of stakeholders and partners including research participants, healthcare professionals, the life sciences industry, academic and research supporting organisations. o The RCSI-CRC Study Feasibility and Activation Manager is expected to enhance clinical trial activity in RCSI-CRC through all of the following core activities: Signposting Promotion Reporting trial activity Streamlining feasibility process, where possible Qualifications: o Degree in a relevant field, for example, Nursing o Good Clinical Practice qualification is required Knowledge & Experience - (Essential): o Three years as a clinical research nurse or other relevant degree with 3 years previous experience and involvement in the conduct of clinical trials. o Be able to demonstrate knowledge of the potential steps in the feasibility process for research studies. o Be able to demonstrate experience in reviewing and understanding the requirements of a clinical trial protocol. o Experience of supporting project plans and implementing them within agreed timelines. o Strong stakeholder management skills with a keen ability to positively influence and negotiate successful outcomes. o Strong ability to effectively manage multiple deliverables simultaneously. o Experience of generating and analysing key metrics to produce and deliver quality information reports for diverse stakeholders. o Experience of motivating high performing stakeholders and fostering a collaborative and supportive culture. o Excellent communication skills with an ability to translate needs and guidance to both clinical and non-clinical stakeholders. o Strong IT and data management skills. Knowledge & Experience (Desirable): o An understanding of GDPR. o Knowledge of hospital approvals process for clinical research. o Knowledge of legislative requirements for clinical research in Ireland. o Knowledge of research governance. "We are all too aware that imposter syndrome and the confidence gap can sometimes stop fantastic candidates putting themselves forward, so please do submit an application - we'd love to hear from you". Application Process Please apply online no later than 5pm on the closing date with your CV and Covering Letter. Informal Enquiries can be directed to Dr Fionnuala Keane, Director of Operations, Clinical Research Centre at. Click here to read our Recruitment and Selection Policy for Researcher.