Senior Clinical Research Associate NZ FLEX at Novotech Global

Auckland, Auckland, New Zealand -

Full Time

Start Date

Immediate

Expiry Date

01 Jun, 26

Salary

0.0

Posted On

03 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Site Management, Relationship Management, ICH GCP Guidelines, Regulatory Requirements, SOP Compliance, Principal Investigator Liaison, Study Coordinator Liaison, Recruitment Strategy, Monitoring Visits, Site Selection, Site Initiation, Site Monitoring, Site Close Out, Contracts Negotiation, Budget Negotiation, Protocol Amendments

Industry

Biotechnology Research

Description

The Senior Clinical Research Associate (SCRA) 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. This role would suit a SCRA who has had exposure to Lead responsibilities and wanting to take a step up into site management. This single sponsor (FSP) role will be based from our Auckland office 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. 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. 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. * Prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed. * 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. 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: * SCRA: seeking 4+ years monitoring experience. Contracts and budgets negotiations post start up and protocol amendments experience would be required for this role. You must have full unrestricted working rights in NZ to be considered for this role. We unfortunately cannot provide sponsorship for this role. 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 Senior Clinical Research Associate is primarily responsible for protecting trial participants' rights and well-being while ensuring reported trial data are accurate and verifiable from source documents. Key duties involve acting as the primary contact between sites, Novotech, and the Sponsor, managing site relationships, and ensuring trials adhere to GCP guidelines and regulatory requirements.