(Senior) Clinical Research Associate

6 months ago


New Zealand BeiGene Full time

**Job Description**:
About the company:

- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 7,700 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.- **Job Description**:
- The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Hematology clinical trials within the country.- The CRA is responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.How you will add value:- Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require
- Conducts co-monitoring visits, if required
- Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Attends onboarding-, disease indication and project specific training and general CRA training as required
- Documents monitoring activities appropriately following ICH-GCP and BeiGene standards
- Conducts Quality Oversight Visits (QOV), as requested
- Completes monitoring visit/ QOV reports timely
- Assists with investigator/site identification
- Assists site to prepare Ethics Committee submissions
- Facilitates clinical trial site contract and budget negotiation
- Manages site queries and communications
- Assists in managing clinical trials, if required
- Establishes regular lines of communication with sites and COMs
- Provides protocol and related study training to assigned sites
- Evaluates the quality and integrity of site practices - escalating quality issues as appropriate
- Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
- Performs additional task as assignedQualification Required:
- Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines- +1 year (Over 4 years for SCRA) of monitoring experience in the pharmaceutical or CRO industry- Excellent communication and interpersonal skills- Excellent organizational skills and ability to prioritize and multi-task- Fluent in English (writing and speaking)- Applicant must have full New Zealand working rights to be considered.
- Additional Job Description
- What we offer to our valued employees:- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan)
- Full-time working from home (with an option to work from the Sydney office, available soon)
- In-house and external learning and development opportunities
- Fantastic benefits program as per the current policy including;
Personal health insurance reimbursement
-Home-office setup allowance
-Monthly reimbursement for home office expenses (i.e. internet, mobile..)
-Group life insurance & income protection insurance
-Wellness benefits (Employee Assistance Program)
-Paid parental leave
-Active social club
-And more as the benefit programs keep improving
- Plus you get to work with a dynamic team of collaborative, supportive, diverse and fun professionals whose mission is clear: Cancer has no borders and neither do we.- BeiGene is proud to be an Equal Opportunity Employer:

- We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity



  • New Zealand ICON plc Full time

    **Clinical Research Associate** **Location: Auckland, hybrid** As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be working alongside a world-leading pharmaceutical company. This 20- year partnership is focused on leveraging...

  • Sr Cra I

    5 months ago


    New Zealand Syneos Health Clinical Full time

    **Description** **Senior Clinical Research Associate I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and...


  • New Zealand Certara Full time

    Overview: Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries. Certara Strategic Consulting is the largest pharmacometric...

  • Senior Associate

    5 months ago


    New Zealand Westpac New Zealand Full time

    Senior Associate / Associate Director - Debt Capital Markets & Syndicate Westpac Banking Corporation (acting through its New Zealand branch) Auckland or Wellington based At Westpac, our Debt Capital Markets & Syndicate team delivers tailored solutions based on in-depth debt capital market knowledge and experience to ensure optimal client outcomes. Mō te...

  • Research Nurse

    4 weeks ago


    New Zealand Syneos Health - Australia Full time

    Research Nurse sought for global organization operating in 45 countries, providing clinical research services to pharmaceutical, healthcare, and medical device industries. Must have experience in clinical research trials, ICH-GCP certification, and excellent communication skills. Competitive pay rates, flexible working shifts, and ongoing training provided.

  • Senior Cra

    5 months ago


    New Zealand ICON plc Full time

    **(Senior) Clinical Research Associate** **Location: New Zealand, Home-based** As a (Senior) Clinical Research Assocaite you will play a key role in improving the lives of patients by accelerating the development of our customers' drugs and devices through innovative solutions. You will be working in partnership with one of our global biotechnology...


  • New Zealand Te Whatu Ora - Health New Zealand Full time

    Join Te Whatu Ora at a key time of change where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centered health system. This is mahi that will improve the health and well-being of everyone in Aotearoa, and we've got an opportunity for you to be part of it **Te whiwhinga mahi | The...

  • Research Nurse

    1 month ago


    New Zealand Syneos Health - Australia Full time

    Description Research Nurse Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience across all study...

  • Associate Finance

    5 months ago


    New Zealand University of Otago Full time

    **FINANCIAL SERVICES DIVISION** **FINANCE ADVISORY** **About our team/M te tma** The University of Otago is New Zealands oldest University and has a strong teaching and research tradition and well-established national and international linkages. It is also one of New Zealands largest universities, with over 20,000 students, assets in excess of $2.0...


  • New Zealand Westpac New Zealand Full time

    Senior Associate, Analyst - Institutional Banking Permanent Full-Time role Based in Britomart, Auckland Ko mātou tēnei | Our Organisation At Westpac New Zealand, our purpose is to help New Zealanders succeed by igniting financial possibilities for our customers, our communities, and for the whole country. Our Institutional and Business Banking teams...


  • New Zealand Te Whatu Ora - Health New Zealand Full time

    **Contribute to transforming the future of health**: - **2 x part-time positions, 1 x 0.5 and 1 x 0.4**: - **Join our Starting Well team and work from where you are** Join Te Whatu Ora at a key time, where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health system. This mahi will...


  • New Zealand Health New Zealand - Te Whatu Ora Full time

    **Contribute to transforming the future of health**: - **Flexible working supported to balance your work and lifestyle**: - **Join our National Systems Design team and work from where you are** Join Te Whatu Ora at a key time, where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health...


  • New Zealand Te Whatu Ora - Health New Zealand Full time

    **Contribute to transforming the future of health**: - **Flexible working supported to balance your work and lifestyle**: - **Join our National Systems Design team and work from where you are** Join Te Whatu Ora at a key time, where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health...


  • New Zealand Te Whatu Ora - Health New Zealand Full time

    **Contribute to transforming the future of health**: - **Part-time role 0.1 FTE**: - **Join our National Systems Design team and work from where you are** Join Te Whatu Ora at a key time, where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health system. This mahi will improve the...


  • New Zealand Health New Zealand - Te Whatu Ora Full time

    **Contribute to transforming the future of health**: - **Flexible working supported to balance your work and lifestyle**: - **Join our National Systems Design team and work from where you are** Join Te Whatu Ora at a key time, where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health...


  • New Zealand Te Whatu Ora - Health New Zealand Full time

    **Contribute to transforming the future of health**: - **Flexible working supported to balance your work and lifestyle**: - **Join our National Systems Design team and work from where you are** Join Te Whatu Ora at a key time, where you will meaningfully contribute to our kaupapa of creating a more equitable, accessible, cohesive and people-centred health...

  • Senior Rangahau

    5 months ago


    New Zealand Te Wananga o Aotearoa Full time

    **About us** Te Wānanga o Aotearoa (TWoA) is New Zealand’s second largest tertiary institution and the world’s largest indigenous tertiary educator, and we’ve been providing transformational education opportunities to New Zealanders for nearly 40 years. Our vision of **‘Whānau transformation through education’** drives our commitment to being at...

  • Senior Central Monitor

    6 months ago


    New Zealand ICON plc Full time

    **Senior Central Monitor** **Location: Home-based, HK** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre...


  • New Plymouth, New Zealand New Zealand Government Full time

    Associate Clinical Nurse Manager - Theatre at Te Whatu Ora - Health New Zealand Taranaki, Taranaki Nau mai, haere mai ki Health New Zealand | Te Whatu Ora Taranaki Improving, promoting, protecting and caring for the health and wellbeing of the people of Taranaki. We are looking for people that share our vision by providing the best care for our people and...


  • New Plymouth, New Zealand New Zealand Government Full time

    Associate Clinical Nurse Manager - Theatre at Te Whatu Ora - Health New Zealand Taranaki, Taranaki Nau mai, haere mai ki Health New Zealand | Te Whatu Ora Taranaki Improving, promoting, protecting and caring for the health and wellbeing of the people of Taranaki. We are looking for people that share our vision by providing the best care for our people and...