Title: Clinical Project Manager
Reports to: Clinical Operations Manager

 

Key Requirements

  1. Science and/or medical or nursing background.
  2. Minimum of 5 years’ CRA and/or Clinical Project Management experience.

 

Main Function(s)

  • Maintain knowledge and ensure compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs (Standard Operating Procedures), study protocols and project-specific procedures.
  • Manage assigned studies in line with CANCER TRIALS IRELAND SOPs and/or other Sponsor SOPs if applicable.
  • Manage successful execution of one or multiple projects.

 

Primary Responsibilities

  • Develop and execute study plans including setting project goals, risk assessment and management, planning resources and timelines, and study team management.
  • Manage performance and development of employees.
  • Manage project-specific training and mentoring.
  • Contribute to preparation for audits and inspections as required.
  • Evaluate and document investigator and site selection.
  • Overall responsibility for management of essential documents and Trial Master File.
  • Oversee the process of study initiations, monitoring and close-out.
  • Develop and maintain study monitoring plan for the duration of the study lifecycle.
  • Review and sign-off initiation, monitoring and close-out reports and documents.
  • Participate in process of protocol development.
  • Identify issues and manage the resolution process for studies under their supervision.
  • Ensure compliance with all applicable CANCER TRIALS IRELAND and/or other Sponsor SOPs if applicable for all studies under their supervision.
  • Input in SOP development and updates where appropriate.
  • Ensure budget agreements and contracts are in place and roles and responsibilities documented prior to commencing study activities.
  • Manage the study budget and associated financial activities for studies under their supervision when applicable.
  • Oversee Regulatory and Ethics committee submissions if applicable.
  • Confirm the necessary processes are in place for study drug and other supplies for studies under their supervision when applicable.
  • Take all reasonable precautions to ensure patient confidentiality is maintained.
  • Organise and attend meetings as required.
  • Prepare and make presentations as required.
  • Update CPL on the status of all clinical trial activities.
  • Identification and communication of scientific misconduct.
  • Maintain strong relationships with external stakeholders.
  • Prepare study reports as required.
  • Perform other tasks as specified by Head of Operations and Clinical Programs

 

 

 

Title: Clinical Research Associate
Reports to: Clinical Operations Manager

 

Key Requirements

  1. Biological/ life sciences, pharmacy, chemistry and/or medical or nursing background.
  2. Minimum of one year clinical research experience or equivalent.

 

Main Function(s)

  • Maintain knowledge of ICH-GCP, applicable regulatory requirements and guidelines, SOPs (Standard Operating Procedures), study protocols and study-specific procedures.
  • Co-ordination of clinical trial activities for assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures.

 

Primary Responsibilities

  • Perform activities according to Cancer Trials Ireland and/or Sponsor SOPs (if applicable).
  • Perform investigator and site selection visits.
  • Collect and maintain essential documents as required by ICH-GCP, Cancer Trials Ireland and/or Sponsor SOPs and regulatory requirements/ethics committees.
  • Preparation and review of study related documentation as applicable (Patient Information Leaflets, Informed Consent Forms, Protocols, Case Report Forms and others).
  • Prepare Regulatory Authority and Ethics Committee submissions if required.
  • Perform study initiation visits.
  • Perform monitoring visits according to the study monitoring plan in Ireland and overseas if required.
  • Monitoring and reconciliation of Serious Adverse Events (SAEs).
  • Tracking of clinical trial activities.
  • Take all reasonable precautions to ensure patient confidentiality is maintained.
  • Identification and communication of scientific misconduct.
  • Perform site close-out visits.
  • Prepare reports of site selection, initiation, monitoring and close-out visits and follow-up on outstanding issues.
  • Assist with training, mentoring and development of new and junior CRAs.
  • Communicate on study issues internally at Cancer Trials Ireland and/or with Sponsor (if applicable) and with Investigator and site staff.
  • Meet regularly with the COM to review/update on the status of studies regularly and upon request.
  • Organise and attend Investigator meetings if applicable.
  • Prepare and make presentations as required.
  • Input into SOP development where appropriate.
  • Contribute to preparation for audits and inspections as required.
  • Perform other tasks as specified by COM.

 

Title: Junior Statistician/Programmer
Reports to: Head of Biometrics

 

Key Requirements: Degree/post-graduate in communications/public relations or related field.

1. Third level degree in Statistics / Biomedical/Computer Science or related discipline.
2. Experience in SAS or equivalent programming language.
3. Excellent organisational, communication and time management skills.
4. Excellent attention to detail.
5. Team player as well as ability to work on own initiative.
6. Oncology background/experience an advantage.
7. Proficiency in all Microsoft Office Tools and general computer literacy.

Main Function(s)

  • To perform Statistical and Programming Tasks on assigned studies within Cancer Trials Ireland for Biometrics.

Primary Responsibilities

• Work with Group Statistician in providing statistical support to Cancer Trials Ireland investigators regarding study design, endpoint selection and sample size calculation.
• Provide statistical input to Case Report Form (CRF) and database design, also data management processes.
• Contribute to creation of Statistical analysis plans and perform statistical analysis.
• Program, test and document specific listings and reports (e.g. Safety Monitory Committee reports, Data Safety Monitoring Board (DSMB) reports and End of Study Reports).
• Develop tables for Abstracts as directed by Group Statistician.
• Collaborate with Group Statistician to ensure double programming Quality Control process.
• Analyse, test, document and maintain SAS programs and macros to generate SAS data sets, spreadsheets, data listing, tables and reports.
• Provide technical advice and programming solutions for clinical projects.
• Creation and review of technical specifications and applicable Standard Operating Procedures (SOP) / Study-specific procedures (SSP) / Work instructions.
• Create and maintain study files and other appropriate study documentation.
• Collaborate with team members to plan and deliver on Study Deliverables.
• Adhere to all related procedures and regulations, e.g. Study Guidelines, SOPs, ICH GCP, etc.
• Perform other tasks as specified by Head of Biometrics/Group Statistician.

 

If you are interested in any of the positions above, please contact Ide Fagan directly @ ide.fagan@cancertrials.ie