Senior 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 three years’ clinical research experience or equivalent. Oncology an advantage
  3. Proven leadership both in delivering on project goals and mentoring junior level employees.

 

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).
  • Interact with COM to evaluate project goals, resources and timelines.
  • Assist COM 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 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.

Clinical Data Manager

Reports to Data Lead

 

Key Requirements

  1. Third level degree in biomedical/ life science.
  2. Minimum of five years of experience in a Clinical Data Management environment. Comprehensive knowledge of data management processes.
  3. Experience in clinical data management systems, especially EDC systems such as iMedidata Rave.
  4. Excellent communication skills.
  5. Team player as well as ability to work on own initiative.
  6. Versatility and ability to work to deadlines.
  7. Oncology background/ experience an advantage.
  8. Proficiency in all Microsoft Office Tools.

 

Main Function(s)

  • To perform and lead Data Management tasks on assigned studies within Cancer Trials Ireland.

 

Primary Responsibilities

  • Perform data management tasks on allocated studies from Start-up (e.g. database build specifications) to Close-out Activities (e.g. Database Lock/Archiving) in an effective and efficient manner
  • Proficiency in EDC technical tasks through all stages of a study.
  • Set up and lead Data Management meetings with internal and external team members.
  • Collaborate with team members to plan and deliver on Study Deliverables.
  • Demonstrate excellent organisational and problem-solving skills.
  • Proactively identify Data Management process improvements and efficiencies.
  • Train and mentor other team members in relation to Data Management processes.
  • Adhere to all related procedures and regulations, e.g. Study Guidelines, SOPs, ICH GCP etc.
  • Contribute to the creation, review and updating of Data Management SOPs.
  • Attend out of hours meetings from time to time
  • Perform other tasks as specified by line manager/ CEO.

Trial Coordinator

Reports to: Clinical Project Manager (Radiotherapy)

 

Key Requirements

  1. Science and/or medical or nursing background.
  2. Minimum of 2 years experience as Radiation Therapist or CRA. Preference given to experienced Radiation Therapists
  3. Proven ability to deliver project goals and mentor junior level employees.

 

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.
  • Coordination of clinical trial activities for assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, study protocols and study-specific procedures, Cancer Trials Ireland SOPs and/or other Sponsor SOPs if applicable.
  • Develop and maintain strong working relationships with external stakeholders/Sponsors.

 

Primary Responsibilities

  • Manage and coordinate assigned studies, including development of country specific documents and overseeing regulatory and ethic committee applications.
  • Primary contact for Sponsor and collaborator groups for assigned studies.
  • Manage project-specific training and mentoring.
  • Contribute to preparation for audits and inspections as required.
  • Evaluate and document investigator and site selection as applicable.
  • Overall responsibility for management of essential documents and Trial Master File where applicable.
  • Responsible for the completion of study initiations, monitoring and close-out as required by the study.
  • Identify issues and manage the resolution process for studies under their coordination.
  • Ensure compliance with all applicable Cancer Trials Ireland and/or other Sponsor SOPs if applicable for all studies under their coordination.
  • 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.
  • Take all reasonable precautions to ensure patient confidentiality is maintained.
  • Organise and attend meetings as required.
  • Prepare and make presentations as required.
  • Update Operations Lead/ Head of Operations and Clinical Programs on the status of all clinical trial activities.
  • Identification and communication of scientific misconduct.
  • Prepare study reports as required.
  • Perform other tasks as specified by Line Manager.

Please send your cv directly to ide.fagan@cancertrials.ie

 

Clinical Research Associate

Reports to: Clinical Operations Manager (COM) Full Time

 

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 the COM

Please send your CV directly to ide.fagan@cancertrials.ie if you are interested in any of the above positions