Senior Clinical Research Coordinator
The National Children’s Research Centre (NCRC) is the primary paediatric research institute in Ireland. Based at Our Lady’s Children’s Hospital Crumlin, it funds and provides infrastructure to conduct research into childhood disease and has a national and international reputation for high quality research.
The NCRC is funded by the CMRF Crumlin.
Clinical research is essential to provide an evidence base for improved medicines and treatment of sick children. The Children’s Clinical Research Unit (CCRU) was established in 2010 by the NCRC to provide infrastructure to support clinical teams in the conduct of clinical research at OLCHC and other paediatric centres in Ireland. The CCRU is made up of a team of research staff with the specialist expertise required to conduct clinical trials in children and young adults.
We are currently inviting applications to the role of Senior Clinical Research Coordinator to join our team.
The closing date is 1st January 2019.
Applications to: Mary Costello (CCRU) or Mark Cuskelly (HR)
|Title:||Senior Clinical Research Coordinator|
|Location:||Children’s Clinical Research Unit, National Children’s Research Centre, Our Lady’s Children’s Hospital Crumlin|
|Hours:||35 hours per week|
|Contract:||Full-time two year fixed term|
|Reporting to:||Clinical Research Operations Manager|
Key Duties and Responsibilities may include:
- Key point of contact between the Principal Investigator (PI) and Study Sponsors/CROs for the coordination of clinical trial activities
- Perform liaison role between the PI, Clinical Research Teams and CCRU Management Team
- Work closely with the PI, Research Nurses and multi-disciplinary team to coordinate the operational aspects of the set-up, maintenance and close-out of research studies
- Coordinate the completion of study feasibility assessments, support the CCRU Management team and PI in planning for new studies, and act as lead during study set-up phase
- Support the PI and CCRU Management team in the collection of essential study documents during set-up and throughout study conduct
- Assist with the preparation of ethics and regulatory applications for clinical studies, working closely with the PI and Quality & Regulatory Affairs Manager (QRAM)
- Support the PI and CCRU Management team in the submission of documents required for local hospital approval
- Coordinate study initiation meetings, monitoring visits, and other Sponsor meetings
- Coordinate Research Team meetings
- Create and maintain study files and other required documentation, as required
- Manage the processing, storage and shipment of biological samples
- Manage patient reimbursements in conjunction with the Research Nurses
- Work closely with the CCRU Management team to support invoicing and financial management
- Liaise with the OLCHC Pharmacy Department and OLCHC Laboratory during study set-up and conduct, as required
- Support the team to ensure safety reporting is completed according to study timelines
- Ensure the tracking of study activities and milestones in a timely manner, and provide support to the Clinical Research Operations with CCRU activity tracking and metric generation
- Communicate study progress to the PI, CCRU Management Team and CCRU Oversight Committee, and attend meetings, as required
- Work closely with the QRAM to ensure the implementation of Quality Management System (QMS) policies, Standard Operating Procedures (SOPs) and other QMS documents
- Contribute towards the development and review of study specific Work Instructions and associated documents, as required
- Support the Clinical Teams to ensure compliance with ICH Good Clinical Practice (GCP) for study related activities
- Act as key liaison for sponsor audits and regulatory inspections, working closely with the PI and QRAM
- Support the team in preparing for study closure and archiving
- Complete all assigned training and facilitate ongoing personal development and learning
- Participate in CCRU cross departmental working groups, as required
- Mentor and facilitate the development of other team members, as required
- Perform other project activities and act as study back-up to the team to ensure that study timelines are met, as required
- Represent the Research teams, CCRU and NCRC at events, meetings and networking opportunities, as required
- Assist in the preparation of materials for internal and external communications, including the NCRC annual report and website
- Adhere to CCRU and all relevant hospital or institution policies, SOPs or guidelines at all times.
All duties will be carried out in accordance with ICH-GCP guidelines and all applicable laws and regulations for the conduct of clinical research.
- BSc or equivalent third level qualification
- Minimum 3 years relevant clinical trial experience
- Ability to lead and communicate effectively and in a professional manner
- Excellent interpersonal skills
- An Individual with initiative, capable of problem solving and working independently
- Team player with the ability to motivate colleagues and promote a positive learning environment
- Knowledge of medical/scientific terminology
- Readiness and ability to learn new skills as required by the position
- Excellent attention to detail
- Solid knowledge of Good Clinical Practice (GCP) requirements
- Knowledge of the governance and legislative requirements relating to the conduct of clinical research in Ireland
- Knowledge of electronic data capture systems and the data management process in clinical studies
- Previous experience in a Clinical Research Associate role and working in a clinical environment
- Monitoring and audit experience
Applicants must have the right to work in Ireland.