CCRU Clinical Research Operations Manager


10.30.2018

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. 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.

Acutely aware of the unmet need in childhood disease, we are striving to ensure that children can access high quality and evidence-based treatments in Ireland. As part of ongoing capacity building and strengthening of our paediatric research infrastructure, we are now recruiting a Clinical Research Operations Manager.

This is a new role and an exciting opportunity for a highly motivated candidate to join our team and work in a rewarding and developing area. The role will lead and provide support to the team of Research Nurses and Coordinators as well as be responsible for study feasibility.

 

Job Description:

Title:Clinical Research Operations Manager
Location:National Children’s Research Centre, Our Lady’s Children’s Hospital, Crumlin, Dublin 12
Hours:35 hours per week
Salary:Aligned with CNM3 or equivalent HSCP Grade
Contract:Full-time two year fixed term, with opportunities to extend
Reporting to:CCRU Programme Manager

Key Duties and Responsibilities may include:

Operational Management

  • Manage the day-to-day operational activities of the CCRU
  • Work closely with the CCRU team, Clinical Study Teams and other stakeholders to ensure the smooth conduct of clinical studies from set-up through to study closedown
  • Work closely with the CCRU Programme Manager in the ongoing development of the CCRU and act as their back-up when required
  • Manage and mentor Research Nursing and Study Coordination staff, encouraging and fostering an environment of team work and continuous development
  • Act as study back-up where required
  • Coordinate team meetings and ensure good communication within the team
  • Provide support with the set-up and coordination of other meetings as required
  • Manage the general administration of CCRU offices and coordinate team admin queries
  • Resource planning and allocation of staff across research studies and ongoing monitoring of workload across groups to ensure best use of resources and to identify capacity limitations
  • Liaise with hospital nursing management and nursing staff as required to support research nurse development and research activities
  • Develop and maintain positive working relationships with hospital departments involved in provision of services to support clinical research activity
  • Oversee the set-up of study sample management procedures and link with OLCHC Sample Preparation Room Coordinator and NCRC Lab Manager to arrange training and study specific logistics
  • Coordinate archiving of site files according to GCP and regulatory guidelines and establish central tracking system
  • Provide support with CCRU activity tracking and metric generation
  • Assist with and input into the development of progress reports for the CCRU Oversight Committee and other stakeholders as required
  • Support the CCRU Programme Manager with financial management of study activities as required
  • Contribute to the planning towards the New Children’s Hospital and the integration of clinical research activities in the interim period
  • Perform other duties as required to ensure the delivery of CCRU services

Quality

  • Support the implementation and alignment of the Quality Management System across the CCRU sub-groups
  • Coordinate the development and continued review of Standard Operating Procedures for clinical and operational tasks
  • Maintain systems to ensure that studies are conducted in accordance with ICH GCP guidelines and all relevant legislation and quality standards
  • Support the Quality & Regulatory Affairs Manager in the implementation of corrective and preventative action plans

Study Feasibility and Set-up

  • Act as Site Lead for study feasibility
  • Coordinate and support Investigators to complete and return feasibility questionnaires to study sponsors
  • Ensure that the local study feasibility tracker is maintained
  • Work with study teams to carry out internal feasibility assessments to feed into resource planning, budget development and applications for CCRU support
  • Assist the CCRU Programme Manager in coordinating applications for CCRU support for review by the CCRU Oversight Committee
  • Support the set-up of studies until a Study Coordinator can be assigned
  • Attend pre-study visits and site initiation visits as required

Training & Development

  • Responsible for new CCRU staff inductions
  • Perform competency assessments and performance appraisals for CCRU Study Coordination staff
  • Develop staff training plans, liaising with the clinical study team and HR as required
  • Ensure staff are aware of any clinical guidelines and hospital SOPs relevant to their assigned duties
  • Organise or provide training to staff as required
  • Assist with the development of training material where necessary
  • Promote sharing of knowledge and experience across the team and facilitate ongoing personal development
  • Liaise with Nursing colleagues and other stakeholders to develop the Research Nurse role
  • Complete all assigned training and facilitate ongoing personal development and learning

Communication

  • Represent the CCRU and NCRC at events, meetings and networking opportunities
  • Participate in external working groups as required
  • Contribute to Public & Patient Involvement initiatives
  • Assist in the preparation of materials for external communications including annual report and the NCRC website

All duties will be carried out in accordance with ICH-GCP guidelines, CCRU and any relevant hospital policies and all applicable laws and regulations for the conduct of clinical research.

Requirements:

Essential

  • RCN or RGN with experience of children’s nursing or equivalent HSCP qualification
  • At least 5 years of relevant post qualification experience
  • Minimum 3 years of relevant clinical trial experience
  • Understanding of current Irish medical, academic and health services research environment and knowledge of GCP requirements relating to the conduct of clinical research
  • Experience of managing and leading a team
  • An individual with initiative and good judgement, capable of problem solving and working independently
  • Strong leadership and interpersonal skills with the ability to motivate people and promote a positive team environment
  • Ability to lead and communicate effectively and in a professional manner
  • Versatility and capable of coping with ambiguity and change; can maintain high level of professionalism when working under pressure
  • Ability to manage competing priorities
  • Possess the highest degree of integrity and confidentiality at all times
  • Attention to detail
  • Strong planning and organising abilities
  • Readiness to work to deadlines and flexibility with regard to working hours
  • Good IT skills

Desirable

  • Prior experience in paediatric research
  • Previous experience working in a Clinical Research Facility or pharmaceutical industry
  • Clinical trial monitoring and auditing experience
  • Demonstrated ability to build close working relationships with internal and external stakeholders and influence decision making
  • Demonstrated leadership ability, proactive development, motivation and engagement skills

Apply now