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| POSITION DESCRIPTION | AUSTRALIAN BIOTECH INDUSTRY MARCH 2009 |
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Clinical Trials Coordinator |
| Position Code: | 36 | | Career Level: | 3 |
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Responsible for
Participating in, coordinating activities for, and/or monitoring clinical trials to a high standard of quality and in accordance with relevant regulations and guidelines. |
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Reports To
Clinical Trials Manager. |
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Supervises
No supervisory responsibilities. May act as a mentor for more junior clinical trial team members. |
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Main Activities
Ensuring all activities are conducted in compliance with organisational policies and standard operating procedures as well as regulatory and statutory guidelines.
Assist with the feasibility analyses of clinical trials including the development of budget proposals.
Design, prepare and track key clinical study documentation.
Assist with the identification and sourcing of necessary study resources.
Participate in, coordinate and/or monitor on-study activities.
Handle and account for study drug, and track adverse event reports. Process, store and track biological samples.
Assist with the control and tracking of project milestones.
Participate in and/or coordinate administrative activities such as data entry, analysis and checking.
Prepare clinical study reports.
Perform quality control checking of all study documentation, and organise the appropriate maintenance of relevant clinical equipment.
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Key Skills
Proven experience in a clinical trials environment.
Excellent communication and interpersonal skills.
Well developed planning and coordination skills.
A working knowledge of FDA and European GCP requirements.
Demonstrated initiative, flexibility and attention to detail.
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Internal Contacts
Clinical development team members, other internal personnel as required. |
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External Contacts
Outsource service and goods providers, research nurses, pharmacists, sponsor representatives. |
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Typical Experience
2+ years relevant industry experience coupled with a degree in science or a health care discipline. |
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