Clinical Research Associate

The Role

The CRA involves in the study preparation, planning, implementation, conduct site visits, follow up the clinical academic study to ensure it adheres to regulatory and ethical standards and deliver the study within timeline.  

 Reporting Relationships

The Clinical Research Associate functionally reports to the Project Manager for project specific responsibilities. The position may be mentored and guided by Senior Clinical Research Associates. 

Duties and Key Responsibilities

Study Design

• Coordinate the identification, feasibility assessment and selection of investigators and sites to undertake the stuy
• 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 visit
• Assist in the development of appropriate monitoring tools
• Motivate and train investigators and ensure that the study site personnel have a good understanding of the protocol, and the requirements of the study and that they can fulfil their obligations to conduct the study accurately and to deadlines.

Study Execution

• Motivate investigators and ensure that the study site personnel enrol the target number of eligible subjects within timeline
• Verify quality, completion, and timeliness of data.
• Completely and efficiently resolve data and audits queries and issues.
• Adhere to the study protocol and study procedures manual.
• Adhere to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of adverse events/serious adverse events are reported
• Assist participating centre research staff in the local management of the study where required.

General

• Manage effective communication with the key stakeholders (outside vendors, Research Coordinators, etc).

Skills, Knowledge, and Experience

Education/ Research Background

• Tertiary qualifications in a related science or health care discipline, research background with post-graduate qualifications preferred.
• 2 years experience in clinical operation within an academic, CRO or pharmaceutical environment.
• Excellent working knowledge of ICH/GCP, ethical and regulatory requirements
• Excellent interpersonal skills, presentation skills and the ability to work well and flexibly ie autonomously, in  teams and with a wide range of varying stakeholders
• Excellent organisational skills – ability to organise, take initiative and follow up independently

We offer a flexible and inclusive work culture with excellent staff benefits including salary packaging arrangements and sound learning opportunities.