Clin Trials Admin I - (CYO16)

Clin Trials Admin I - (CYO16)

15 Nov
|
covance
|
Sydney

15 Nov

covance

Sydney

Job Overview:



Job Overview:



- Experienced Clinical Trial Assistant required to work for Covance

- You will be permanently employed by Covance and work within our FSPx department 100% dedicated to one Sponsor

- Ideally you will work full-time 

- Office based Macquarie Park, Sydney

- You must have previous experience working in a CTA type role within clinical research



Discover new opportunities to grow your career as a Covance FSP Clinical Trial Assistant. Our partner has an incredibly exciting and innovative pipeline. This is an incredibly exciting time to be joining Covance as we continue to grow and expand. This is a permanent, full-time role ideally, office-based in Sydney.



What is FSP?



At Covance,

you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).



As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise. 



Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.



With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning. Further information can be found at: https://www.covance.com/services/functional-service-provision.html



Job Primary Functions



As a CPA/CTA, your responsibilities will comprise:



- Support to local study team (CRAs/CLM)

- Assistance in tracking of documents (e.g. CA, financial agreements, contact cards, diaries, insurance certificates)

- Assistance in preparation of submission package to ECs/HA (initial, substantial amendments, DETF, CSR) and submission to EC/CAs

- Circulate and distribute Investigator brochures and track accordingly

- Maintenance of correspondence with Global Study Team and site personnel

- Support and maintain constructive relationships with external partners (e.g. investigators, study coordinators, CROs) and internal partners (e.g. RA, Legal, PV, Import/Export Dept., Controlling, Finance)

- Assistance in preparation, support during conduct of audits and inspections of study documents

- Perform and/or coordinate translations of study documents

- Initiate the order of equipment for office staff (e.g. IT-equipment, office supplies

- May accompany CRAs/CLMs to investigator sites

- Processing of invoices and tracking of study budget

- Organization and support of meetings (incl. TCs)

- Support and/or attend and follow-up of local team meetings and local investigator meetings

- Logistic of the attendance of site staff to the investigators' meeting: invitations, travel organization, reimbursement of expenses

- Set-up, maintenance, preparation for archiving and QC checks of the TMF

- Prepare and initiate new starter process of all new members of GCO and StM team

- Support in study drug logistic management

- For drugs returned to sponsor -Order packing materials for disposal (forms, containers, labels), prepare and coordinate transfer of drugs for destruction.



Education/Qualifications:



Recommended: Minimum Required:  Diploma – Associate degree or equivalent?



Or In lieu of the above requirement, candidates with 1-2 or more years of relevant Clinical Research experience in pharmaceutical or CRO industries may be considered



Experience:



Minimum Required:  Minimum one (I) year administrative experience or equivalent training  Good oral and written communication skills  Good organizational and time management skills  Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint) Preferred:  Aptitude for handling and proof-reading numerical data, some spreadsheet software competency  Good typing skills  Good spelling and proof-reading skills  Ability to operate standard office equipment (e.g., fax, copier)  Works efficiently and effectively in a matrix environment

The original job offer can be found in Kit Job:
https://www.kitjobau.com/job/8532290/clin-trials-admin-cyo16-sydney/?utm_source=html

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