Clinical Research Associate II/III - NSW

The Clinical Research Associate (CRA), 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

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.

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.