Clinical Research Associate; Trial Monitor - Brazil

• Job Title: Clinical Research Associate (Trial Monitor - Brazil)
• Reporting Relationship: Clinical Project Manager
• Employment Duration: 2 years
• Type of Employment: Part-time (0.8
  
  FTE), fixed-term

The Project Operations team in UK works closely with our Research teams globally to ensure study aims are achieved. The team is primarily responsible for the set-up, conduct and overall delivery of projects across all research programs in The Institute, according to best practice guidelines and research budgets.

The Clinical Research Associate (CRA) is required to assist the Project Manager with various tasks associated with running clinical studies. Generally, the CRA performs all monitoring tasks required at study sites, including source data verification, safety reporting, drug accountability and the maintenance of study documentation. The CRA provides regular study updates and monitoring visit reports to the Project Manager and updates clinical study tracking systems as necessary.

The CRA may be required to travel frequently to Brazil including multiple day stays, as required to conduct on-site monitoring visits at investigative sites. This includes pre-study visits, site initiation visits, routine monitoring, and close-out visits, in accordance with the study protocol, Good Clinical Practice (GCP), and applicable regulatory requirements. The CRA must be adaptable to changing travel schedules, capable of managing time effectively while on the road, and committed to maintaining a high standard of data quality and site support during all visits.

The CRA is responsible for oversight and management of trial sites within Brazil and will be the main point of contact between the Brazilian sites and the trial team globally.

The CRA will also be required to assist with any other project related tasks, outside of Brazil.

The CRA reports to Project Managers within the UK & Australian Project Operations teams. The CRA will also develop effective working relationships with the study site staff and the Australian and India Project Operations team.

• Assist with the identification and selection of investigators/sites to undertake the study
• Conduct feasibility assessments
• Prepare, plan, organise and conduct pre-study (site selection) visits and report on these visits to assist in site selection
• Assist in the preparation of documentation for ethics submission
• Create, organise and collate documents required by the project team prior to the start of the study (e.g. protocols, questionnaires, feasibility, confidentiality agreements, etc.)
• Assist in the development of appropriate monitoring tools
• Organise and participate in investigator meetings
• Prepare for, plan, organise and conduct site initiation visits
• Collect and review essential documents from study sites
• Motivate and train investigators.

• Perform study monitoring by visit, email and telephone to the participating study sites to ensure:
• Data quality, accuracy, completeness and timeliness of data completion
• Complete and efficient resolution of data queries
• Adherence to the study protocol and study procedures manual
• Adherence to ICH/GCP and other guidelines and requirements as relevant to this trial
• Complete monitoring visit reports accurately and within the predetermined timeframe
• Coordinate distribution, tracking, handling and destruction of study supplies per site
• Assist study site research staff in the local management of the study where required.
• Collect and review essential documents from study sites and ensure they are complete at study close-out and appropriately stored/managed in-house

• Assist Project Manager with other study-related activities such as organising study meetings and scheduling travel, producing agendas and minutes for study-related meetings, responding to protocol and data collection enquiries, maintaining study documentation, assisting in the preparation of budgetary and administrative documents and other tasks as required.
• Manage effective communication with the key stakeholders (including the Study Management Committee, Principal Investigators, Research Coordinators, etc.).
• Assist with global project requirements as requested, including contributing to project tasks deemed necessary by the project manager for all regions and countries, where the trial is being conducted.

• Participate in activities to improve processes, tools, systems and organisation;
• Take responsibility for personal learning and development and for setting achievable and meaningful work objectives and managing personal targets, meeting obligations of The Institute’s Performance Management and Development Policy;
• Demonstrate commitment to The Institute’s organisational values, including performing to an exceptionally high ethical standard and focus on integrity, collaboration and teamwork in all efforts.

• Comply with Work Health and Safety legislation and operate in…