HPG·5 days ago
5 days ago
Clinical Research, Study Start Up Specialist
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What you'll do
- Coordinate ethics and governance activities across new and existing clinical trials.
- Prepare, review, and manage HREC submissions and associated research documentation.
- Coordinate site governance applications, regulatory requirements, and study amendments.
- Respond to queries from ethics committees, governance offices, sponsors, and other stakeholders.
- Manage study start-up timelines and ensure approval milestones progress efficiently.
- Coordinate documentation required to move studies from initial start-up through to site activation.
- Work closely with sponsors, CROs, investigators, and internal research teams throughout the approval process.
- Support clinical trial agreements, budgets, feasibility, and other start-up activities as required.
What they're looking for
- Previous experience working with HREC and research governance processes is essential.
- Demonstrated experience preparing, coordinating, or reviewing human research ethics applications.
- Experience within clinical trial start-up, research governance, clinical research administration, or a related environment.
- Good understanding of Australian clinical research ethics and governance requirements.
- Strong organisational skills with the ability to independently manage multiple submissions and deadlines.
- Excellent written communication and confidence engaging with researchers, sponsors, CROs, and governance stakeholders.
- Tertiary qualification in Health, Life Sciences, or a related discipline.
Nice to have
- Exposure to site-specific assessments, CTN processes, study amendments, or regulatory documentation is highly regarded.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Benefits
Join a growing Australian clinical research organisation supporting the delivery of sponsored clinical trials in partnership with pharmaceutical, biotechnology, and research organisations.
With an increasing portfolio of clinical studies, the organisation provides a collaborative environment where experienced research professionals can take ownership of study start-up and contribute to the continued development of clinical research capability.
About the Opportunity
An opportunity exists for a Clinical Research Start-Up Specialist to coordinate clinical trial activation, with a particular focus on ethics, governance, and regulatory submissions. You will manage activities across the start-up lifecycle, working closely with sponsors, CROs, investigators, research teams, and governance stakeholders to progress studies efficiently towards activation. The position offers considerable autonomy and would suit someone with established HREC and research governance experience who is confident managing multiple submissions, navigating approval requirements, and driving study start-up timelines.
Duties
Join a growing and collaborative research environment where people are encouraged to take ownership, contribute ideas, and improve how studies are delivered. The team values quality, agility, and practical problem-solving, offering experienced professionals the autonomy to manage their work while collaborating closely across clinical operations.
How to Apply
Click apply or contact Rohan Lallbeeharry – Senior Recruitment Consultant – at rlallbeeharry@hpgconnect.com or call +61 485 860 660 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.
- Attractive salary package with salary packaging benefits.
- Take ownership of ethics, governance, and clinical trial start-up activities.
- Work across a growing portfolio of sponsored clinical research studies.
- Highly autonomous role within a collaborative and expanding specialised research team.
Join a growing Australian clinical research organisation supporting the delivery of sponsored clinical trials in partnership with pharmaceutical, biotechnology, and research organisations.
With an increasing portfolio of clinical studies, the organisation provides a collaborative environment where experienced research professionals can take ownership of study start-up and contribute to the continued development of clinical research capability.
About the Opportunity
An opportunity exists for a Clinical Research Start-Up Specialist to coordinate clinical trial activation, with a particular focus on ethics, governance, and regulatory submissions. You will manage activities across the start-up lifecycle, working closely with sponsors, CROs, investigators, research teams, and governance stakeholders to progress studies efficiently towards activation. The position offers considerable autonomy and would suit someone with established HREC and research governance experience who is confident managing multiple submissions, navigating approval requirements, and driving study start-up timelines.
Duties
- Coordinate ethics and governance activities across new and existing clinical trials.
- Prepare, review, and manage HREC submissions and associated research documentation.
- Coordinate site governance applications, regulatory requirements, and study amendments.
- Respond to queries from ethics committees, governance offices, sponsors, and other stakeholders.
- Manage study start-up timelines and ensure approval milestones progress efficiently.
- Coordinate documentation required to move studies from initial start-up through to site activation.
- Work closely with sponsors, CROs, investigators, and internal research teams throughout the approval process.
- Support clinical trial agreements, budgets, feasibility, and other start-up activities as required.
- Previous experience working with HREC and research governance processes is essential.
- Demonstrated experience preparing, coordinating, or reviewing human research ethics applications.
- Experience within clinical trial start-up, research governance, clinical research administration, or a related environment.
- Good understanding of Australian clinical research ethics and governance requirements.
- Exposure to site-specific assessments, CTN processes, study amendments, or regulatory documentation is highly regarded.
- Strong organisational skills with the ability to independently manage multiple submissions and deadlines.
- Excellent written communication and confidence engaging with researchers, sponsors, CROs, and governance stakeholders.
- Tertiary qualification in Health, Life Sciences, or a related discipline.
Join a growing and collaborative research environment where people are encouraged to take ownership, contribute ideas, and improve how studies are delivered. The team values quality, agility, and practical problem-solving, offering experienced professionals the autonomy to manage their work while collaborating closely across clinical operations.
How to Apply
Click apply or contact Rohan Lallbeeharry – Senior Recruitment Consultant – at rlallbeeharry@hpgconnect.com or call +61 485 860 660 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.
Company
HPG
Melbourne, Australia
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