Clinical Research Associate II - SA at Novotech Global

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

17 May, 26

Salary

0.0

Posted On

16 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Time Management, Attention To Detail, Teamwork, Computer Literate, Site Relationship Management, ICH GCP Guidelines, Regulatory Requirements, SOP Adherence, Relationship Building, Recruitment Planning, Monitoring, Site Selection, Site Initiation, Site Monitoring, Site Close Out

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 South Australia 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 You 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). Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance. Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. 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 primary responsibility is ensuring participant rights and data accuracy while acting as the main contact between investigational sites, Novotech, and the Sponsor. Key duties involve site relationship management and ensuring clinical trials adhere to ICH GCP guidelines, local/global regulations, and SOPs.