Platinum Recruitment has partnered exclusively with Pacific Edge, a global leader in cancer diagnostics, for the appointment of a Clinical Research Assistant (CRA) or a Clinical Trials Associate (CTA). The role will be an integral part of Pacific Edge’s New Zealand operations (Pacific Edge Pty Ltd).
You are an experienced Clinical Research Assistant or Clinical Trials Associate with excellent organisational and people skills. You are looking for a role with a vibrant company that is making a positive difference in the lives of people around the world and thrives at being on the edge.
What we need from you: Our continued growth means we now have an exciting role for an exceptional individual genuinely interested in development and coordinaiton of Cxbladder clinical trials. If that person is you, you will use your clinical trials expertise and experience to help build our Cxbladder evidence portfolio.
The Job: This is a new role for Pacific Edge Pty Limited (Pty is a subsidiary of Pacific Edge Limited, PEL). The incumbent for this role will operate as a member of the PEL group reporting to the VP Clinical Research and Product Performance (Clinical Director) and will be based in Dunedin, New Zealand. The nature of the Company’s business is the development and commercialisation of novel diagnostic tests for the detection and management of cancer.
The CRA or CTA will be responsible for the day-to-day management of designated clinical trials and Cxbladder User programs designed by the Clinical Director in conjunction with Pacific Edge executive management. This will include input into the development and co-ordination of investigator selection, analysis of potential patient recruitment, preparation of trial related documentation (study protocols, case report forms (CRFs), investigators brochures, consent documents, letters of agreement, confidentiality agreements).
Importantly the CRA or CTA will be responsible for the administration, follow up and reconciliation of queries generated by the Pacific Edge data management team and will be responsible for the monitoring of clinical site data, remotely and at clinical site. The CRA or CTA will also be responsible, as needed, for organising Ethics committee submissions, with appropriate follow up to ensure successful outcome on time and to specification.
This is a permanent, full-time position, Monday to Friday 8.30am – 5.00pm, with some flexibility. The CTA/CRA operates both strategically and tactically within the clinical science team to drive effective clinical trials generating high quality data and evidence.
Duties and Responsibilities: To ensure the clinical and product trials are managed and implemented on time and to specification to ensure the best outcomes for Pacific Edge Pty Limited. As part of the role the incumbent will need to:
- Perform investigative site management activities in accordance with global study protocols and in line with Pacific Edge Pty Ltd expectations
- Assist with study start-up and close-out activities including distribution of study material for ethics submission, collection of site regulatory approval documents, review of essential documents for accuracy and completeness, and obtaining information from investigative sites
- Track and record study recruitment efforts at the site level and assist the study team in preparing study metrics
- Communicate with investigative sites on a weekly basis regarding pertinent study issues such as recruitment and enrolment, study supply needs, clinical tracking information, compliance issues, etc.
- Track site monitoring documentation (visit confirmation letters, monitoring visit reports, close-our letters) to ensure that files are complete and appropriately filed for each site.
- Prepare, handle, distribute, file and archive study documentation and reports in the Trial Master File; review files for overall accuracy and completeness; work with investigative sites to correct any deficiencies identified.
- Participate in the review and distribution of clinical SOPs and other study related documentation such as protocols, amendments, etc.
- Live the Company’s values.
- Has practical hands-on experience running and managing clinical trials.
- Must be a highly organised individual with strong analytical, research and statistical skills.
- Good problem solving with a solid understanding of scientific data collection and management methods.
- Advanced written and verbal communication skills are necessary, as is the ability to interact with healthcare professionals, researchers, clinical trial sponsors and trial participants.
- Excellent computer skills and proficiency with spreadsheets are essential.
- Outstanding presentations skills and high attention to detail.
- Conveys company ethos and values in a professional and empathetic way.
- Understands and complies with corporate and patient confidentiality.
- Excited to learn more about our cancer diagnostic products and how they contribute to improving patients’ lives.
- Genuine, warm and friendly personality to help build authentic relationships with customers and internal teams / stakeholders.
You will get a unique opportunity to work with a diverse team of experts who will share their knowledge with you. You will gain valuable exposure and real-life experiences which will assist you in your future career.
To be considered for this position, please apply with a cover letter and current resume outlining your relevant experience to Andrew Wilson via email to firstname.lastname@example.org, or call in confidence on 027 752 8465.
Do you have expertise in, and passion for, Clinical Research? Would you like to apply your expertise to impact the effectiveness and medication of products in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! We’re investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success.
What you’ll do
You are a self-motivated, proactive, and passionate individual focused on delivering quality outcomes in a fast-paced environment. The new Clinical Research Associate (initial 12 month contract, full-time basis), will be involved in effective site management across a number of high-profile studies as well as all aspects of the study from preparation, initiation, monitoring, and closure. To be successful in this role you will have good knowledge of Clinical Study Management across monitoring, study drug handling and data management. You will ideally have experience working in a similar capacity, have excellent knowledge of international guidelines ICH-GCP, relevant local regulations and a basic understanding of the drug development process.
Key responsibilities include, but not limited to:
- Contributing to the selection of potential investigators and training, supporting, and advising investigators in regards to study related matters including Risk Study start-up and regulatory maintenance
- Initiating, monitoring, and closing study sites in compliance with AZ Procedural Documents. This includes participating in Local Study Team (LST) meetings and sharing information on patient recruitment and study site progress
- Updating CTMS and other systems with data from study sites
- Performing monitoring visits (remotely and on site), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan
- Performing regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study
Essential for the role
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH‐GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
Desirable for the role
- Ability to work in an environment of remote collaborators.
- Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Good analytical and problem‐solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Familiar with risk‐based monitoring approach including remote monitoring.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work.
So, what’s next?
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have a seat available and we hope it’s yours.
- If you’re curious to know more than please reach out to Danielle Jones.
Where can I find out more?
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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