Clinical Research Associate II
3 weeks ago
We are seeking a highly skilled Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key Responsibilities- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
- Conduct Source Document Review of appropriate site source documents and medical records.
- Verify required clinical data entered in the case report form (CRF) is accurate and complete.
- Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
- Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
- Verify site compliance with electronic data capture requirements.
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
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Clinical Research Associate II
2 weeks ago
Sydney, New South Wales, Australia Pharmiweb Full timeJob Title: Clinical Research Associate IIAs a Clinical Research Associate II at Pharmiweb, you will be part of a dynamic team that is dedicated to delivering high-quality clinical research services to our clients. We are seeking a highly motivated and experienced CRA II to join our team in Italy.Key Responsibilities:Conduct on-site monitoring visits to...
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Clinical Research Associate II
2 weeks ago
Sydney, New South Wales, Australia Pharmiweb Full timeJob Title: Clinical Research Associate IIAs a Clinical Research Associate II at Pharmiweb, you will be part of a dynamic team that is dedicated to delivering high-quality clinical research services to our clients. This role will involve working on a variety of projects, including clinical trials, observational studies, and other research initiatives.Key...
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Clinical Research Associate II
1 week ago
Sydney, New South Wales, Australia Pharmiweb Full timeJob Title: Clinical Research Associate IIWe are seeking a highly motivated and experienced Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for managing clinical studies at participating sites, ensuring the quality of site performance, and closing clinical studies.Key Responsibilities:Evaluate,...
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Clinical Research Associate II
1 week ago
Sydney, New South Wales, Australia BeiGene Full timeJob Description:The Clinical Research Associate II (CRA II) plays a crucial role in the successful execution of clinical trials within the country. As a key member of the clinical team, the CRA II is responsible for ensuring the quality and integrity of clinical trial data, while adhering to Good Clinical Practice (GCP) and International Conference on...
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Clinical Research Associate II
3 days ago
Sydney, New South Wales, Australia BeiGene Full timeJob Description:The Clinical Research Associate II (CRA II) plays a crucial role in the successful execution of clinical trials within the country. As a key member of the clinical team, the CRA II is responsible for ensuring the quality and integrity of clinical trial data, while adhering to Good Clinical Practice (GCP) and International Conference on...
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Clinical Research Associate II
2 weeks ago
Sydney, New South Wales, Australia Pharmiweb Full timeJob Title: Clinical Research Associate IIWe are seeking a highly motivated and experienced Clinical Research Associate II to join our team. The successful candidate will be responsible for leading the design, planning, coordination, and conduct of clinical research studies for in vitro diagnostics.Responsibilities:Ensure studies are conducted and documented...
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Clinical Research Associate II
2 weeks ago
Sydney, New South Wales, Australia Pharmiweb Full timeJob Title: Clinical Research Associate IIWe are seeking a highly motivated and experienced Clinical Research Associate II to join our team. The successful candidate will be responsible for leading the design, planning, coordination, and conduct of clinical research studies for in vitro diagnostics.Responsibilities:Ensure studies are conducted and documented...
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Clinical Research Associate II
3 weeks ago
Sydney, New South Wales, Australia BeiGene Full timeJob Description:The Clinical Research Associate II (CRA II) plays a crucial role in the successful execution of clinical trials within the country. As a key member of the clinical team, the CRA II is responsible for ensuring the quality and integrity of clinical trial data, while adhering to Good Clinical Practice (GCP) and International Conference on...
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Clinical Research Associate II
6 days ago
Sydney, New South Wales, Australia BeiGene Full timeJob Description:The Clinical Research Associate II (CRA II) plays a pivotal role in the successful execution of Oncology and Hematology clinical trials within the country. As a key member of the clinical team, the CRA II is responsible for delivering high-quality data within established timelines, ensuring adherence to monitoring procedures in accordance...
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Clinical Research Associate II
10 hours ago
Sydney, New South Wales, Australia BeiGene Full timeJob Description:The Clinical Research Associate II (CRA II) plays a pivotal role in the successful execution of Oncology and Hematology clinical trials within the country. As a key member of the clinical team, the CRA II is responsible for delivering high-quality data within established timelines, ensuring adherence to monitoring procedures in accordance...
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Clinical Research Associate II
2 weeks ago
Sydney, New South Wales, Australia BeiGene Full timeJob Description:The Clinical Research Associate II (CRA II) plays a pivotal role in the successful execution of Oncology and Hematology clinical trials within the country. As a key member of the clinical team, the CRA II is responsible for delivering high-quality data within established timelines, ensuring adherence to monitoring procedures in accordance...
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Clinical Research Associate II
5 days ago
Sydney, New South Wales, Australia BeiGene Full timeJob Description:The Clinical Research Associate II (CRA II) plays a pivotal role in the successful execution of Oncology and Hematology clinical trials within the country. As a key member of the clinical team, the CRA II is responsible for delivering high-quality data within established timelines, ensuring adherence to monitoring procedures in accordance...
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Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full timeTransforming Patient Outcomes through Clinical ResearchAt SYD Fortrea Australia Pty Ltd, we're committed to revolutionizing healthcare through cutting-edge research and innovation. As a Clinical Research Associate II, you'll play a critical role in ensuring the success of our global clinical trials.Key Responsibilities:Monitor clinical trials to ensure...
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Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full timeJob Title: Clinical Research Associate IIAt Fortrea, we're seeking a highly motivated and experienced Clinical Research Associate II to join our team. As a key member of our global clinical trials team, you will be responsible for ensuring compliance and maintaining top-tier data integrity in our clinical trials.Key Responsibilities:Monitor clinical trials...
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Clinical Research Specialist II
2 weeks ago
Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full timeCompany Overview: SYD Fortrea Australia Pty Ltd is a premier global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise. We provide a comprehensive suite of clinical development, patient access, and technological solutions across a diverse range of therapeutic areas. With a workforce...
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Clinical Research Specialist II
2 weeks ago
Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full timeCompany Overview: SYD Fortrea Australia Pty Ltd is a premier global contract research organization (CRO) committed to scientific excellence and innovation in clinical development. With extensive experience spanning over three decades, we offer a comprehensive suite of clinical development, patient access, and technological solutions across a multitude of...
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Clinical Research Specialist II
2 weeks ago
Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full timeAbout SYD Fortrea Australia Pty Ltd: As a premier global contract research organization (CRO), SYD Fortrea Australia Pty Ltd is dedicated to scientific excellence and has extensive experience in clinical development. We offer a comprehensive array of clinical development, patient access, and technological solutions across over 20 therapeutic areas. With...
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Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full timeTransforming Patient Outcomes through Cutting-Edge ResearchAt SYD Fortrea Australia Pty Ltd, we're revolutionizing the development process to ensure the swift delivery of life-changing ideas and therapies to patients in need. As a Clinical Research Associate II, you'll be at the forefront of global clinical trials, ensuring compliance and maintaining...
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Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full timeJob Title: Clinical Research Associate IIAt Fortrea, we're seeking a highly motivated and experienced Clinical Research Associate II to join our team. As a key member of our global clinical trials team, you will be responsible for ensuring compliance and maintaining top-tier data integrity in our clinical trials.Key Responsibilities:Monitor clinical trials...
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Sydney, New South Wales, Australia SYD Fortrea Australia Pty Ltd Full time**About SYD Fortrea Australia Pty Ltd**As a leading global contract research organization (CRO), SYD Fortrea Australia Pty Ltd provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.**Our Mission**We are dedicated to...
