Clinical Research Associate

Overview

• Coordinate and manage clinical monitoring activities across all trial phases and therapeutic areas
• Full service CRO with in-house regulatory affairs consultancy
• Sydney-based role with multiple positions available across NSW

Benefits

• Work for a leading CRO across Asia-Pacific
• Regular training and international knowledge-sharing opportunities
• Get exposure to a diverse range of therapeutic areas

About the company
Our client is a respected global CRO with an established presence across multiple regions, providing end-to-end clinical development services to pharmaceutical, biotechnology and medical device organisations.
About the opportunity
Acting as the primary link between the sites and the sponsor, the CRA will coordinate and manage clinical monitoring activities from site start-up through to close out.
Duties

• Prepare, organise, conduct and follow-up routine monitoring and close out visits as per relevant study plan
• Motivate and train investigators and site staff to ensure obligations in regard to study timelines
• Ensure compliance with ICH/GCP, study protocols and other applicable regulatory guidelines
• Oversee all ethics submissions and trial reporting
• Follow company SOP’s and adapt knowledge and processes as applicable to the therapeutic area
• Contribute to process improvements and protocol review

Minimum requirements

• Tertiary degree in life sciences or relevant subject
• Minimum 12 months independent monitoring experience with a strong track record of performing site visits according to the Clinical Monitoring Plan
• Experience working in a CRO environment
• Oncology monitoring experience highly regarded
• Solid knowledge of GCP and national and international regulations, with a sound understanding of how they apply to your role
• Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments
• Full Australian working rights

Culture
Fast paced and adaptable CRO that sets a high benchmark for clinical trial operations across the Asia-Pacific. Join an inclusive, collegiate team that places a strong emphasis on supporting its people and valuing their contribution to organisational and client success.
 
How to Apply
Click apply or contact Davina Ocansey-Gibson, Specialist Manager on [+61 2 8877 8712](tel:+61 2 8877 8712) or via email [email protected] for a confidential discussion.
 
About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.

• Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific
• Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs
• Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse
• Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing

For more job opportunities, visit www.hpgconnect.com.