Initiation Clinical Research Associate I

1 month ago

North Ryde, Australia Parexel Full time

When our values align, there's no limit to what we can achieve.
 

Study Start-up Associate hiring: 1-2 years' experience in start up experience is needed.

We are open to consider experienced Study Coordinator with start up activities experience from site level.

Key Accountabilities:

Start-up (from site identification through pre-initiation):

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.

Build relationships with investigators and site staff. Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:

-Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
-Conduct remote Qualification Visits (QVs).

Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution. Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation. Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments. Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval. Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy. Forecast, develop, manage, and revise plans and strategies for:

-IRB/IEC and MoH / RA submission/approval,
-Site activation,
-Patient recruitment & retention.

Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner. Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc. Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start. Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections Work in a self-driven capacity, with limited need for oversight. Proactively keep manager informed about work progress and any issues.

  • Initiation Clinical Research Associate I

    4 weeks ago

    North Ryde, Australia Parexel Full time

    Study Start-up Associate hiring: 1-2 years' experience in start up experience is needed. We are open to consider experienced Study Coordinator with start up activities experience from site level. **Key Accountabilities**: **Start-up (from site identification through pre-initiation)**: Act as Parexel’s direct point of contact with assigned sites,...

  • Initiation Clinical Research Associate I

    1 month ago

    North Ryde, Australia Parexel Full time

    Study Start-up Associate hiring: 1-2 years' experience in start up experience is needed. We are open to consider experienced Study Coordinator with start up activities experience from site level. **Key Accountabilities**: **Start-up (from site identification through pre-initiation)**: Act as Parexel’s direct point of contact with assigned sites,...

  • Clinical Research Associate Team Lead

    4 weeks ago

    North Ryde, New South Wales, Australia Parexel Full time

    We are seeking an experienced Clinical Research Associate I to join our team at Parexel. The successful candidate will have 1-2 years of experience in start-up activities and be open to considering experienced Study Coordinators with similar experience from a site level.The Key Accountabilities for this role include:Start-up (from site identification through...

  • Clinical Research Associate I

    7 months ago

    North Ryde, Australia Parexel Full time

    **Key Accountabilities**: **Start-up (from site identification through pre-initiation)**: Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. - Build relationships with investigators and site staff. - Conduct, drive and manage country specific feasibility and/or site...

  • Clinical Research Associate I

    4 months ago

    North Ryde, Australia Parexel Full time

    1. We are open to consider talents experienced in great Study Coordinator, Clinical Research Coordinator, Clinical Trial Coordinator, or equivalent roles. 2. We are open to consider talents with Inhouse CRA, CTA experience from CRO/ Pharma 3. We are open to consider talents with 6-12 months CRA experience **Key Accountabilities**: **Start-up (from site...

  • Clinical Trial Associate

    1 week ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL Join the Macquarie University Clinical Trials Unit team and support ground-breaking research into new medications for patients with a range of diseases and illnesses. Grow your career in clinical trials with a great team! - Appointment type: Full time, Fixed term position for 2 years - Salary Package: From $80,753 to $91,815 p.a. (HEW 5),...

  • Clinical Research Governance Administrator

    1 month ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL Clinical research governance and regulatory support for MQ Health and Macquarie University- Salary Package: HEW 5 circa $83,580 (negotiable) per annum, plus 17% superannuation and annual leave loading- Appointment Type: Full time, one year fixed-term- Macquarie University (Wallumattagal Campus, North Ryde) The Role About You Ideally you...

  • Clinical Research Governance Officer

    1 month ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL Clinical research governance and regulatory support for MQ Health and Macquarie University- Salary Package: HEW 6 circa $96, 273 (negotiable) per annum, plus 17% superannuation and annual leave loading- Appointment Type: Full time, fixed term two years- Macquarie University (Wallumattagal Campus, North Ryde) The Role About You Ideally you...

  • Clinical Genomics Research Coordinator

    1 month ago

    North Ryde, New South Wales, Australia Macquarie University Full time

    About the RoleWe are seeking a highly skilled and motivated Clinical Genomics Research Coordinator to join our team at Macquarie University's Centre for Economic Impacts of Genomic Medicine (GenIMPACT).Key ResponsibilitiesCoordinate recruitment, consent, and data collection for research grants on the economic and social impact of genetic conditions.Undertake...

  • Research Assistant

    7 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL An exciting opportunity exists for a Research Assistant - Clinical Genomics to join our dynamic team. THE ROLE Salary Package:  From $83,580 to $95,029 (HEW Level 5) p.a., plus 17% employer's superannuation and annual leave loading (pro-rata when moved to a Part-time role). Appointment Type: Maternity Leave replacement....

  • Clinical Trials Start Up

    7 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL - Salary Package: From $115,030 to $127,995 p.a. (HEW Level 8), plus 17% employer's superannuation and annual leave loading - Appointment Type: Full time, continuing (permanent) - 35 hour working week with opportunities for flexible working arrangements - Macquarie University (Wallumattagal Campus, North Ryde) location THE ROLE We are...

  • Project Lead, Motor Neurone Disease Research

    3 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL Provide expert project management, implementation and research support for the Pilot Motor Neurone Disease (MND) Surveillance Unit in New South Wales research project within Macquarie Medical School.- Salary Package: HEW 7 from $108,391 + 17% employer superannuation and annual leave loading- Appointment Type: Full-time, 2 years fixed term-...

  • Educational Governance and Initiatives Manager

    7 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL - Salary Package: From $109,552 to $121,901 per annum (HEW Level 8), plus 17% employer's superannuation and annual leave loading. - Appointment Type: Full-time, 18-month parental leave cover - Location: Macquarie University, Wallumattagal Campus, North Ryde THE ROLE An exciting opportunity exists for an experienced and proactive Educational...

  • Mixed-methods Researcher

    3 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL We are seeking a Mixed-Methods Researcher to be part of a team that brings together healthcare consumers, clinicians, health and medical researchers to improve children’s healthcare. The Role- Salary range: Level A, $106,089 - $113,697 p.a. or Level B, $119,839 - $141,790 p.a. (pro rata) plus superannuation.- Fixed-term, full-time until 31...

  • Research Assistant

    3 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL Exciting opportunity for an enthusiastic Research Assistant with an interest in molecular biology and cell culture to contribute to research programs in the Dementia Research Centre.- Salary Package: From $83,580 p.a.to $95,029 p.a. (HEW Level 5), plus 17% employer's superannuation and annual leave loading- Appointment Type: Full time, fixed...

  • Accreditation and Educational Initiatives Officer

    6 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL - Salary Package: $93,017 - $102,676 (HEW 6) p.a. plus 17% employer’s superannuation and annual leave loading - Appointment Type: Full Time / Fixed-Term (12-month appointment) - Location: Macquarie University, Wallumattagal Campus (North Ryde) THE ROLE The Educational Governance and Initiatives team in the Faculty of Arts is looking for an...

  • Research Assistant

    7 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL Exciting opportunity for an enthusiastic Research Assistant with an interest in Neuroscience to work on a project focusing on the development of novel gene therapies for the treatment of epilepsy THE ROLE- Salary Package: From $80,753 - $91,815 (HEW 5) plus 17% superannuation and annual leave loading- Appointment Type: Fixed Term Contract...

  • Associate Clinical Consultant

    2 months ago

    North Ryde, Australia Johnson & Johnson Full time

    Associate Clinical Consultant - Abiomed - Great Place to Work® Certified - 2024 - Competitive salary package, flexible work practices, award winning benefits - Continuous training and development ABOUT THE COMPANY Join our mission-driven team dedicated to recovering hearts and saving lives. Your expertise will directly contribute to improving patient...

  • Research Assistant

    2 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL Research Assistant position in Ophthalmology and Vision Research Group Salary Package: $76, 654 (HEW4). pro-rata, plus 17% superannuation Appointment Type: Part-time (0.4FTE), 3-year fixed term Location: Macquarie University (North Ryde) Wallumattagal Campus About the opportunity Research assistant role within the Ophthalmology and...

  • Associate Clinical Specialist

    4 weeks ago

    North Ryde, Australia Johnson & Johnson Full time

    Great Place to Work® Certified - 2024 - Competitive salary package, flexible work practices, award winning benefits - Role based in Sydney ABOUT THE COMPANY Brief role intro THE OPPORTUNITY We have an exciting opportunity for an Associate Clinical Specialist to join our NSW team supporting our dynamic Biosense Webster business. As an Associate Clinical...