In-house Cra I

1 week ago

Port Melbourne, Australia Labcorp Full time

1) To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.

2) To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.

3) To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).

4) To perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.

5) To assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples.

7) To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.

8) To liaise with Study Start-up and assume maintenance activities after Site Activation. Maintenance responsibilities including but not limited to: revision of FDA form 1572 or equivalent, Medical license expiration, CV (if applicable), Laboratory Certificate expiration, Protocol Signature Page collection, Investigators Brochure acknowledgement of receipt, Institutional Review Board submission/Approval for Annual Renewals and PI Changes.

9) To proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.

10) To demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections. To enter weekly details in CTMS or as per study requirement.

11) To liaise with the CTA to assist the Project Team in the production of Status Reports.

12) To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.

13) To assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region

14) General On-Site Monitoring Responsibilities

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement.

  • In-house Clinical Research Associate I

    1 week ago

    Melbourne, Victoria, Australia Fortrea Full time

    Job Overview The In-House Clinical Research Associate (IHCRA I) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the IHCRA I shall reflect their experience, and level of contribution which they can make to the project. The work will involve Clinical...

  • In-house Clinical Research Associate I

    1 week ago

    Melbourne, Victoria, Australia Fortrea Full time

    Job OverviewThe In-House Clinical Research Associate (IHCRA I) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the IHCRA I shall reflect their experience, and level of contribution which they can make to the project. The work will involve Clinical Operations...

  • CRA II

    3 weeks ago

    Melbourne City Centre, Victoria, Australia ICON CLINICAL RESEARCH PTY LIMITED Full time

    CRA II - Senior CRAICON plc • Melbourne, AustraliaABOUT ICON:ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I – IV clinical...

  • ▷ Apply Now: CRA II

    6 days ago

    VIC - Melbourne - CBD & Surrounds, Australia ICON CLINICAL RESEARCH PTY LIMITED Full time

    CRA II - Senior CRA ICON plc • Melbourne, Australia ABOUT ICON: ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I – IV...

  • Cra Ii

    2 weeks ago

    Melbourne, Victoria, Australia Icon Full time

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • Senior Clinical Research Associate I

    2 weeks ago

    Melbourne, Victoria, Australia Fortrea Full time

    Senior Clinical Research Associate I (SCRA1), FSP model Join to apply for the Senior Clinical Research Associate I (SCRA1), FSP model role at Fortrea Senior Clinical Research Associate I (SCRA1), FSP model3 days ago Be among the first 25 applicants Join to apply for the Senior Clinical Research Associate I (SCRA1), FSP model role at Fortrea Job Overview The...

  • In House Clinical Research Associate

    2 weeks ago

    Melbourne, Victoria, Australia Medpace, Inc. Full time

    Job Summary:We are currently seeking a full-time, office-based **In-House CRA** to join our team in Australia (Melbourne). If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.Responsibilities:- Serve as a resource to CRAs by conducting site management and...

  • Cra Ii/ Scra I

    2 weeks ago

    Melbourne, Victoria, Australia Syneos Health, Inc. Full time

    Updated:September 2, 2025Location:AUS-RemoteJob ID:Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient...

  • CRA II/ SCRA I

    3 weeks ago

    Melbourne, Victoria, Australia Syneos Health, Inc. Full time

    OverviewUpdated: September 2, 2025Location: NZL-RemoteJob ID: 25000423Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer...

  • CRA II/ SCRA I

    3 weeks ago

    Melbourne, Victoria, Australia Syneos Health, Inc. Full time

    OverviewUpdated: September 2, 2025Location: NZL-RemoteJob ID: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and...