Clinical Research Associate

• Part time (0.8 FTE)
• 1 year fixed term contract
• Respected global research organisation
• Make an impact on global health outcomes

• Find better treatments for the world’s biggest health problems
• Transform primary health care to support better health for more people
• Harness the power of communities, governments and markets to improve health

Our innovative commercial enterprises help maximise our impact.

An exciting opportunity exists for a Clinical Research Associate (CRA) to join our growing organisation.

The Clinical Research Associate (CRA) is required to assist the Project Manager with various tasks associated with running a large-scale clinical trial. 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.

Key responsibilities of the role will include:

Study Design

• Assist with the identification and selection of investigators to undertake the study
• Conduct feasibility assessment
• 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, plan, organise and conduct pre-study (site selection) visits and report on these visits to assist in site selection
• Prepare for, plan, organise and conduct site initiation visits
• Collect and review essential documents from study sites
• Motivate and train investigators

Study Execution

• Perform study monitoring by visit, email and telephone to the participating centres 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 participating centre research staff in the local management of the study where required

General

• 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)

Our ideal candidate will possess:

• Tertiary qualifications in a related science or health care discipline
• Previous monitoring experience working on clinical projects within an academic, CRO or pharmaceutical environment
• Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions
• Basic understanding of medical terminology
• Knowledge of ICH/ GCP guidelines
• Understanding of confidentiality and privacy laws and all guidelines relevant to medical research
• Excellent skills in MS Office applications including Excel and Word
• Excellent interpersonal skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders
• Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs
• Ability and willingness to travel

This is a great opportunity for you to work on exciting projects and make an impact on global health outcomes. To learn more about the role, please view the Position Description here.

The closing date for applications is Wednesday 30th September 2020. Please note, however, that we reserve the right to close this vacancy early if a suitable candidate is found.