Clinical Research Associate II/III - NSW at Novotech Global

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

24 Sep, 26

Salary

0.0

Posted On

26 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Monitoring, ICH GCP Guidelines, Site Relationship Management, Regulatory Compliance, Time Management, Attention To Detail, Teamwork, Computer Literacy, Site Recruitment, Project Delivery, Ethics Submission, Clinical Trial Management

Industry

Biotechnology Research

Description

The Clinical Research Associate (CRAII - CRAIII), is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs. This role will be based in Sydney and we offer hybrid working arrangements and full flexibility in working hours to ensure our staff achieve the work-life balance often missing in this role. Minimum Qualifications & Experience Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. For our current opportunities we require experience of working in the research, pharmaceutical industry or a related field per job level as follows: * CRA II: minimum of 6 months of CRA independent monitoring experience * CRA III: 2+ years of CRA independent monitoring experience ou must have full unrestricted working rights in Australia to be considered for this role. We unfortunately cannot provide sponsorship for this role. Responsibilities: * CRAs primary responsibility is to build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited and smooth management of clinical trials. * Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines. * collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed. * In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials. * Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required. * Monitoring of investigational sites as per ICH GCP This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Novotech is a global full-service clinical Contract Research Organization (CRO). At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do. Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact. At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. At Novotech you will work alongside empowered teams with a shared commitment to success. * Strategic vs transactional mindset. * Ability to gain insights and make proactive decisions quickly. * Culture that fosters partnership and collaboration, where every voice is heard and valued. * Ongoing support from senior stakeholders and leadership team. .

Responsibilities

The CRA is responsible for protecting trial participants' rights and ensuring trial data is accurate and verifiable. They act as the primary contact between investigational sites, the sponsor, and Novotech to ensure compliance with GCP and regulatory requirements.