Clinical Trial Administrator

3 days ago

Melbourne, Australia Labcorp Full time

Are you looking to develop your career in the drug development sector?

If so Labcorp has opened an excellent opportunity for a person to get their career started as a Clinical Trial Administrator (CTA)

In this role you will manage the administrative and business activities related to the conduct of clinical trials (registrational and non-registrational /Investigator Sponsored Research Studies) with investigative sites from study start-up to study closure.

**Responsibilities include**:

- Setting up vendors during study startup period (operational details from sites)
- Enter necessary data / tracking in systems (i.e.ECLIPSE, eTMF, SAP)
- Responsible for documentation within the electronic master file (uploading / completing documents) & other systems including conduct of completeness checks
- Arranging drug and non-drug (Lab kits, ECG) importation to support study site
- Complete all payment activities including preparing invoices, Payment Due Reports and creating fund/PO
- Collect and distribute documents from / to sites during study life cycle
- Coordinate study related materials (i.e. protocol, Informed Consent Form(ICF), patient material) for translation
- Coordinate study related documents (IB, Protocol, Site ICF etc.) for printing and binding
- Administrative support to the study team (study related mailing, bill processing, printing, translation etc.)
- Obtain Insurance certificates
- Preparing On Site Investigator File and other study related files
- Support equipment calibration and tracking
- Archiving process handling at study closure
- May support Local GRS in preparing and/or performing submission for Health Authorities including follow up until approval. This could include preparation and/or submission of substantial amendments.
- May prepare and perform submission for Ethics Committees including follow up until approval (protocol, amendments/IB)
- May support Health Authority inspection and pre-inspection activities
- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

**Experience**:

- Degree within Life Sciences area, Administrative, Financial or Accounting related field preferred, or minimum 2 years working experience in any of these areas in addition to high school degree or local equivalent
- Ideally at least 1+ years of experience in Clinical Research or related work experience

**Must Have**:

- Basic understanding of GCP, ICH Guidelines and local regulations as they apply.
- Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow.
- Experience in managing multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals.
- Demonstrates ability to function independently
- Able to work from the client office 5 days per fortnight (50% of the time)

**Preferred**:

- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent

**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.

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