POSITION SUMMARY:

The role of the Clinical Trial Assistant is to support the practice and development of the clinical research programme of Beaumont Hospital Cancer Services and its affiliates. The Clinical Trial Assistant will assist the Clinical Data Management team and the Clinical Research Nurse team in the delivery of specified clinical trials. The Clinical Trial Assistant may be required to aid the implementation of quality improvement initiatives within the cancer clinical trials unit. They may carry out non study-specific duties and study-specific-duties (where delegated by Principal Investigators) and as instructed by Programme Manager. The Clinical Trial Assistant will provide support to the Programme Manager in the setting up, delivery of and the closing off of clinical trials across the portfolio and according to study life cycle. Other duties will be assigned from time to time by the CCTU Program Manager.

Responsibilities:

• Assist the Clinical Data Management team in management of medical records needed for source data entry requirements
• Provide administrative assistance to the Programme Manager, the Clinical Data Management team and Clinical Research Nurse team
• Log, track and maintain central laboratory supplies as agreed with the Clinical Data Management team and Clinical Research Nurse team
• Provide feedback to relevant staff on an on-going basis if deficits in resources are identified
• Ensure upkeep of Investigator Site Files for assigned studies according to ICH-GCP
• Help to facilitate monitoring visits by Clinical Research Associates
• Assist with internal and external audits as required.
• Maintain the storage of study & patient records in accordance with policy.
• Preparation of relevant documentation, including collecting and tracking medical charts if required.
• Contacting other hospitals regarding retrieval of histopathological and radiological material as per protocol requirements in consultation with Clinical Research Nurse team.
• Perform general Administrative duties: eg
• Minute taking, Collecting and sorting the post,
• General filing, photocopying, scanning and faxing of documents.
• Maintain databases for Investigator Site File archiving
• Adhere to hospital policy on confidentiality and data protection.

EDUCATION AND TRAINING

• Assist the Clinical Data Managers and Clinical Research Nurse team in maintaining up to date training records of all staff within the CCTU and without.
• Liaise with Programme Manager in management of career development pathway.
  This job profile is not to be viewed as an inflexible specification but as an outline of the principal duties and responsibilities applicable at present. The duties of the post may change from time to time in response to organisational priorities and in consultation with the post holder.
  Qualifications:

• Assist the Clinical Data Management team in management of medical records needed for source data entry requirements
• Provide administrative assistance to the Programme Manager, the Clinical Data Management team and Clinical Research Nurse team
• Log, track and maintain central laboratory supplies as agreed with the Clinical Data Management team and Clinical Research Nurse team
• Provide feedback to relevant staff on an on-going basis if deficits in resources are identified
• Ensure upkeep of Investigator Site Files for assigned studies according to ICH-GCP
• Help to facilitate monitoring visits by Clinical Research Associates
• Assist with internal and external audits as required.
• Maintain the storage of study & patient records in accordance with policy.
• Preparation of relevant documentation, including collecting and tracking medical charts if required.
• Contacting other hospitals regarding retrieval of histopathological and radiological material as per protocol requirements in consultation with Clinical Research Nurse team.
• Perform general Administrative duties: eg
• Minute taking, Collecting and sorting the post,
• General filing, photocopying, scanning and faxing of documents.
• Maintain databases for Investigator Site File archiving
• Adhere to hospital policy on confidentiality and data protection