Clinical Research Associate II/III - NSW
- Ensure the rights and wellbeing of trial participants are protected.
- Act as the primary contact between Investigational Sites, Novotech and Sponsor.
- Manage clinical trials in accordance with ICH GCP guidelines and regulatory requirements.
Send Message to Team
0 ) ? ' oj-md-8 ' : ' oj-sm-12 ') ]]" style="box-sizing: border-box; flex-basis: 100%; flex-grow: 0 !important; flex-shrink: 1 !important; max-width: 100%; scrollbar-color: rgba(49, 45, 42, 0.15) rgba(0, 0, 0, 0); scrollbar-width: thin; width: 1126px;">
Basic info
Requisition Status
Open - Posted
Requisition Type
Standard
Requisition Number
4490
Requisition Title
Clinical Research Associate II/III - Sydney
Number of Openings
1
Requisition Template
Business Justification
Replacement
Languages
American English (Default)
Hiring team
-
Hiring Manager
Daniela CaiazzaVice President Clinical Services ANZ
-
Recruiter
Pat NgSenior Talent Acquisition Specialist
-
Collaborator
Passant ZakiDirector Clinical Operations
Actions
-
Collaborator
Priyanka SharmaSenior Talent Acquisition Specialist
Actions
-
Collaborator
Kaye SambellsSenior Clinical Operations Manager
Actions
Requisition structure
Recruiting Type
Non Executive Level 1
Organization
Novotech (Australia) Pty Ltd, Novotech Health Holdings
Job Family
Job Function
Primary Location
Australia
Other Locations
Details
Worker Type
Employee
Regular or Temporary
Regular
Full Time or Part Time
Full time
Education Level
Employee being replaced:
Luke Adair
Requisition Cancel Reason
Work Preferences
-
Travel Required
International Travel Required
Willing to Relocate
Work Duration Months
Posting description
InternalExternal
Short Description
Description
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.
We vet all employer accounts and do our best to keep job ads safe, but scams can still occur. Be cautious when sharing personal information — never provide financial details or make payments during the application process. For extra security, use the Apply button on our site when proceeding.