Job details

Location
Macquarie Park
Salary
12% Performance Bonus
Job Type
Full Time
Ref
BBBH35094_1597811469
Contact
Davina Ocansey
Contact email
Email Davina
Contact phone
+61288778712
Posted
about 1 month ago

Job details

Location
Macquarie Park
Salary
12% Performance Bonus
Job Type
Full Time
Ref
BBBH35094_1597811469
Contact
Davina Ocansey
Contact email
Email Davina
Contact phone
+61288778712
Posted
about 1 month ago

Benefits

A step-up opportunity for a CRA

Gain project management experience

Work for a global company

Minimal travel at 30%-40%

Flexible working arrangements

About the company

A global healthcare company and a market leader

About the opportunity

The focus of this position is the management and co-ordination of clinical research projects across all phases

of clinical development

Duties

Assessing the feasibility, logistics, timeframes, and budget of clinical studies

Designing the study protocol local clinical trials

Writing and reviewing of study reports/presentations

Coordinating the preparation of documentation for Ethics and Governance submissions

Collecting and maintaining regulatory documentation

Identifying and selecting investigators to undertake clinical trials, arranging and participating in meetings

Mentor / coach CRAs including regular site visits

Liaise with the CRAs to ensure that the documentation for each clinical study is complete, and correct within set time frames

Reporting & follow up of Serious Adverse Events (SAE)

Skills and Experience

Nursing or biological science qualification

>5 years experience in medical device industry

Minimum of 3 years monitoring experience

Knowledge of TGA regulations for clinical trials and adverse event reporting requirements

Ability to effectively identify, plan, schedule and co-ordinates the resources required to accomplish goals

Culture

A dynamic and supportive culture that are focused on employee training and development

How to Apply

Click apply or contact Christine Bristol, Executive Consultant on +61 2 8877 8766 for a confidential discussion.

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