Title: CRA II/Senior Clinical Research Associate
Reports to: Clinical Operations Manager
- Biological/ life sciences, pharmacy, chemistry and/or medical or nursing background.
- Minimum of four years’ clinical research experience or equivalent.
- Proven leadership both in delivering on project goals, and mentoring junior level employees.
- 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.
- Perform activities according to Cancer Trials Ireland and/or Sponsor SOPs (if applicable).
- Interact with CPM/CPL to evaluate project goals, resources and timelines.
- Assist CPM/CPL with Project Management activities as required.
- 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 CPM/CPL 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 CPM/Line Manager/CPL.
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.
- To perform Statistical and Programming Tasks on assigned studies within Cancer Trials Ireland for Biometrics.
• 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 @ firstname.lastname@example.org