Clinical Research Associate

Reports to: Clinical Operations Manager (COM)

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.

Clinical Trial Administrator

Reports to: Clinical Operations Manager (COM)

Key Requirements
1. Full working knowledge of and competence with Microsoft Office.
2. Proven organisational skills.
3. Working knowledge of clinical trial process an advantage.
4. Science/ nursing qualification an advantage.

Main Function(s)
• To provide support to Clinical Operations Department (Project Management, Site Management, Ethics and Regulatory Coordination, Data Management, Pharmacovigilance)

Primary Responsibilities may include:
• Preparation and maintenance of in-house Trial Master Files and Investigator Site and Pharmacy Files, including filing and tracking of clinical trial documents.
• Assist in the archiving of study documents.
• Assist with Data Management review of clinical trial data and creation and tracking of Case Report Form (CRF) and Data Clarifications Forms (DCFs).
• Ordering of clinical trial supplies and Investigational product.
• Assist with the preparation of Regulatory Authority and Ethics Committee submissions.
• Assist with the preparation and submission of applications to obtain hospital approval.
• Ordering and sending clinical trial documents.
• Assist in the tracking and filing of safety data/ reports by the Pharmacovigilance team.
• Responsible for main reception phone during absence of administration staff.
• Coordinate queries and direct issues to appropriate clinical research personnel.
• Coordinate the preparation, collection, tracking and filing of essential documents including centralised documents (Investigator/ investigational site staff CVs, Investigator Agreements, GCP certificates, laboratory accreditation, etc.)
• Maintain and build strong relationships with key customers.
• Assist in the preparation of Cancer Trials Ireland Scientific and Education/DSSG meetings and other meetings.
• Assist with training administration and preparations for training courses.
• Assist in update and maintenance of Cancer Trials Ireland membership details.
• Perform other tasks as assigned.

Clinical Trial Coordinator

Reports to: Clinical Operations Manager (COM) Full Time

Key Requirements

  1. Science and/or medical or nursing background.
  2. Minimum of 2 years’ Clinical Research experience.
  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.

 

 

Clinical Project Manager

Reports to: Head of Operations & Clinical Programs –  Full Time

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

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