Clinical Research Associate NZ

About the Company At Novotech, we are dedicated to advancing clinical research and ensuring the highest standards of safety and efficacy in our trials. We pride ourselves on being an inclusive workplace that values diversity and gender equality. Our team is composed of passionate professionals who are committed to making a difference in the clinical research and biotechnology sectors. About the Role We are seeking a Clinical Research Associate (CRA II - SCRA) who will play a vital role in protecting the rights and wellbeing of trial participants while ensuring the accuracy and completeness of trial data. As the primary liaison between investigational sites, Novotech, and our sponsors, you will manage site relationships and ensure that clinical trials adhere to ICH GCP guidelines, local and global regulatory requirements, as well as Novotech and client standard operating procedures. We offer hybrid working arrangements and full flexibility in working hours, promoting a healthy work-life balance for our staff. Requirements To qualify for this role, candidates should have a degree in a clinical or life sciences-related field. Relevant experience or qualifications in allied professions may also be considered. Strong time management skills, attention to detail, and the ability to work effectively in a team are essential. Proficiency in computer use is required. We have specific experience requirements for different job levels: - CRA II: A minimum of 6 months of independent monitoring experience as a CRA - CRA III: At least 2 years of independent monitoring experience as a CRA - SCRA: A minimum of 4 years of independent monitoring experience Candidates must have full, unrestricted working rights in Australia, as we are unable to provide sponsorship for this role. Responsibilities As a Clinical Research Associate, your primary responsibility will be to build strong relationships with Principal Investigators, study coordinators, pharmacists, and other relevant trial personnel to facilitate the efficient management of clinical trials. You will foster both internal and external customer relationships to ensure timely and productive project delivery in accordance with study requirements and timelines. Collaboration will be key in this role. You will work closely with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-up Associate (RSA) to prepare site essential documents and support the ethics and regulatory submission and approval processes as needed. Additionally, you will work with the Regulatory Start-up (RSU) Team to understand the applicable local and international regulatory requirements specific to clinical trials. You will be responsible for ensuring the recruitment of participants meets site targets, driving recruitment and engagement initiatives, and preparing site-specific recruitment plans as necessary. Your monitoring responsibilities will include all types of visits throughout the clinical trial phases, which may be conducted onsite or remotely as outlined in the Clinical Monitoring Plan. Benefits At Novotech, we are committed to providing an exceptional workplace. We offer flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development opportunities. We recognize that our team members have diverse needs and responsibilities, and we strive to support them in achieving a fulfilling work-life balance. We welcome applications from individuals who are passionate about clinical research and biotechnology, including those who identify as LGBTIQ+, have disabilities, or have caring responsibilities. We are proud to be a Circle Back Initiative Employer, and we commit to responding to every application. We look forward to connecting with you regarding your application.