Clinical Research Associate

1 week ago


Macquarie Park, Australia Healthcare Professionals Group Full time

**Overview**
- Work directly for a sponsor
- Carry out monitoring activities across a wide range of trials
- Remote / on-site hybrid role

**Benefits**
- Work for a top tier multinational pharmaceutical company
- Close knit and supportive team with great developmental opportunities
- Work on some exciting new product portfolios
- Attractive salary package

**About the company**

Our client is a market leading pharmaceutical company that are creating some lifesaving medicines that are changing people lives worldwide. This company has a global presence with expanding operations in Australia and New Zealand.

**About the Role**

The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies, following appropriate documentation, while liaising with the clinical team, site staff and project managers.

**Responsibilities**
- Obtain and maintain essential documentation in compliance with ICH-GCP, procedural documents and local regulations both in the office and at site.
- Initiate, monitor and close study sites in compliance with procedural documents, share information on patient recruitment and study site progress with project managers.
- Train, support and advise investigators and site staff and contribute to team meetings.
- Drive performance at the sites by proactively identifying study-related issues and escalate as appropriate.
- Update database and other systems with data from centres as per study requirements, perform source data verification and ensure data query resolution.
- Manage study supplies, drug supplies and drug accountability at study sites.
- Manage pharmacovigilance and ensure adverse events are reported.
- Assist in audit preparation and regulatory inspections by working with cross functional departments.
- Provide the required monitoring visit reports within required timelines.
- Work with data management to ensure quality of the study data.
- Ensure compliance with company's internal SOP’s, work processes and policies

**Minimum Requirements**
- University degree in life sciences, or related discipline.
- Full driving license and ability to travel nationally as required.
- Minimum of 18 months local independent monitoring experience.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Pharmaceutical experience, ideally have worked in a sponsor or CRO environment.
- Full Australian working rights.

**Company Culture**

The company values and rewards accountability, collaboration, and hard work. These values are fundamental to the company and are why they deliver excellent results and create lifesaving medicines helping patients around the globe.

**How to Apply**
Davina Ocansey, Senior Recruitment Consultant on +61 2 8877 8712

**Job details**:

- Location
- Macquarie Park
- Salary
- Attractive salary package
- Job Type
- Contract
- Ref
- BH-40037
- Contact
- Davina Ocansey
- Contact phone
- +61 2 8877 8712
- Posted
- about 4 hours ago



  • Macquarie Park, Australia MSD Full time

    Clinical Research Associate or Senior Clinical Research Associate Permanent fulltime role with competitive remuneration and benefits Required for individual to be based in Sydney, Melbourne, or Brisbane Work with a high performing, agile and passionate team Both CRA and SCRA encouraged to applyThe role is accountable for performance and compliance for...


  • Macquarie Park, Australia MSD Full time

    **Clinical Research Associate (CRA)** - ** Permanent, full-time** role with competitive renumeration and benefits - Required for individual to be based in **Sydney, Australia, Macquarie Park**: - Work with a **high performing, agile and passionate team**: - ** Opportunity to work in an area your passionate about**, whilst being fully supported and...


  • Macquarie Park, Australia AstraZeneca Full time

    Are you passionate about making a positive and impactful difference to the lives of others through Clinical Research? Join AstraZeneca as a Clinical Research Associate working on the BioPharmaceutical pipeline. **About AstraZeneca** Our belief powers us to push the boundaries. As we improve success rates, we keep moving forward. Celebrating both successes...


  • Macquarie Park, Australia AstraZeneca Full time

    Are you passionate about making a positive and impactful difference to the lives of others through Clinical Research? Join AstraZeneca as a Senior Clinical Research Associate working on the Biopharmaceutical pipeline. **About AstraZeneca** We are a biopharmaceutical company driven by a strong sense of purpose, bringing a patient-centric approach to...


  • Macquarie Park, Australia AstraZeneca Full time

    Are you passionate about making a positive and impactful difference to the lives of others through Clinical Research? Join AstraZeneca as a Senior Clinical Research Associate working on the Biopharmaceutical pipeline.About AstraZenecaWe are a biopharmaceutical company driven by a strong sense of purpose, bringing a patient-centric approach to everything we...


  • Macquarie Park, Australia MSD Australia Full time

    Job DescriptionClinical Research Associate (CRA)Permanent, full-time role with competitive renumeration and benefitsRequired for individual to be based in Sydney, Australia, Macquarie Park Work with a high performing, agile and passionate teamOpportunity to work in an area your passionate about, whilst being fully supported and encouragedThe role is...


  • Macquarie Park, Australia MSD Full time

    **Clinical Trials Start-Up/Operations Associate** - ** Looking for a different challenge as an **Clinical Trials Start-Up/Operations Associate **whereby you can still utilise your skills? - ** Permanent Full-time **position with **competitive renumeration **and** benefits** - Location**:Macquarie Park, Sydney** - Modern office environment, a **dedicated and...


  • Macquarie Park, Australia MSD Full time

    **Clinical Trials Start-Up/Operations Associate** - ** Looking for a different challenge as an **Clinical Trials Start-Up/Operations Associate **whereby you can still utilise your skills? - ** Permanent Full-time **position with **competitive renumeration **and** benefits** - Location**:Macquarie Park, Sydney** - Modern office environment, a **dedicated and...


  • Macquarie Park, Australia AstraZeneca Full time

    Do you have experience in clinical operations and a passion for excellence? An exciting new opportunity to use your expertise to help us identify quality and process improvements within our newly formed Oncology Clinical TeamAbout AstraZenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery,...


  • Macquarie Park, Australia MSD Full time

    Opportunity to join a leading global biopharma company Exciting chance to work with passionate and collaborative teams Be at the centre of innovation and excellence in execution.Our Clinical Research and Pharmacovigilance team pushes global healthcare boundaries through research and innovation. Through clinical trials and surveillance, we ensure the safety...


  • Macquarie Park, Australia MSD Full time

    With support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. The aCRM could be responsible...


  • Macquarie Park, Australia MSD Full time

    Clinical Trials Start-Up/Operations Associate- Looking for a different challenge as an Clinical Trials Start-Up/Operations Associate **whereby you can still utilise your skills?- Permanent Full-time position with competitive renumeration and benefits Location:Macquarie Park, Sydney Modern office environment, a dedicated and welcoming team- Upskill and...


  • Macquarie Park, Australia MSD Full time

    With support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.The aCRM could be responsible...


  • Macquarie Park, Australia Healthcare Professionals Group Full time

    Overview Work directly for a sponsor Carry out monitoring activities across a wide range of trials Remote / onsite hybrid roleBenefits Work for a top tier multinational pharmaceutical company Close knit and supportive team with great developmental opportunities Work on some exciting new product portfolios Attractive salary packageAbout the companyOur client...


  • Macquarie Park, Australia AstraZeneca Full time

    Do you have experience in clinical operations and a passion for excellence? An exciting new opportunity to use your expertise to help us identify quality and process improvements within our newly formed Oncology Clinical Team! **About AstraZeneca** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the...


  • Macquarie Park, Australia MSD Full time

    Associate Clinical Operations Manager I (aCOM-I) Permanent fulltime role with competitive renumeration and benefits Work with a high performing, agile and passionate teamThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality...


  • Macquarie Park, Australia MSD Full time

    Associate Clinical Operations Manager I (aCOM-I) Permanent fulltime role with competitive renumeration and benefits Work with a high performing, agile and passionate teamThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality...


  • Macquarie Park, Australia MSD Australia Full time

    Job DescriptionClinical Trials Start-Up/Operations AssociateLooking for a different challenge as an Clinical Trials Start-Up/Operations Associate whereby you can still utilise your skills?Permanent Full-time position with competitive renumeration and benefitsLocation: Macquarie Park, SydneyModern office environment, a dedicated and welcoming teamUpskill and...

  • Research Associate

    2 weeks ago


    Port Macquarie, New South Wales, Australia Charles Sturt University Full time

    Diverse and varied areas of research Unique opportunity to develop your skills Regionally based campuses with remote working opportunity The RoleFixed Term, Part time (Duration and FTE dependent on the project funding) Level A - $91,465 (plus 17% superannuation) – Prorated to FTE Albury-Wodonga, Bathurst, Dubbo, Orange, Port Macquarie, Wagga Wagga (Remote...


  • Macquarie Park, Australia Macquarie University Hospital Full time

    PRIMARY DETAIL As an experienced Senior Perioperative Nursing Manager, we want you to bring your private healthcare experience to MQ Health and Macquarie University. - Join an organisation that seamlessly links the research and clinical practice to provide outstanding patient outcomes - Full time senior perioperative nursing role across our dynamic...