Clinical Research Associate

Study Design:

The Clinical Research Associate would be expected to:

• 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.

The Clinical Research Associate should also:

As a Team Member:

• Participate in team meetings and activities relating to assigned project(s) and own work area;
• Participate in special projects 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 GI’s values, including performing to an exceptionally high ethical standard and focus on integrity, collaboration and teamwork in all efforts.

Work, Health and Safety

• Comply with GI’s Work Health and Safety Policy and related procedures, and similar policies which apply when visiting the premises of affiliates and collaborating sites.
• Promote and contribute to a safe, secure environment for staff and visitors.

Skills, Knowledge and Experience

• Qualifications: Bachelors/ Masters in basic life sciences
• Tertiary qualifications in a related science or health care discipline
• Previous onsite and remote 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.
• Demonstrated capability to produce outcomes and achieve objectives within agreed time periods;
• Strong problem solving, analytical skills, and proven strategic thinking;
• Ability to demonstrate flexibility and to be adaptable to changing organisational priorities and ambiguous environments;
• Well organised and efficient, with the capacity to work under pressure;