CTA

As an important member of the clinical team you will be responsible for administrative support of all study-related activities. This includes start-up activities, study related documentation, logistical arrangements and working with operations, site and regulatory staff. Your tasks will include

Study start up activities
- Coordinating preparation of local study documentation relating to: clinical study timelines for all studies conducted in a country, recruitment plans and strategy, informed consent form, draft clinical metrics reports
- Preparing and maintaining local study documentation
- Reconciling study documents
- Collating study specific data and generating local metrics reports
- Coordinating local data entry into study management systems
- Creating and completing tracking documentation as applicable
- Processing, distributing and tracking essential documents and submitting them in compliance with SOPs
- Ensuring provision of appropriate clinical documents to support regulatory submission
- Preparing and tracking confidentiality agreements
- Collating and distributing study supplies to sites
- Providing support responding to local audits and inspections
- Responding to clinical trial queries
- Ordering, processing and tracking Case Report Forms (CRF) and following-up on query resolution if required
- Acting as a single contact point for Clinical Trials Insurance process
- Coordinating the preparation of the submissions and local tracking of applications to IRB/ IEC
- Initiating and validating payment requests as required, ensuring that payment requests are within contract and based on milestones
- Completing tracking documentation as applicable including but not limited to spreadsheets, study and contract tracker

Working experience in an administrative role, preferably within clinical research (CTA experience ideal)

-     Good working knowledge of common software packages

-     Ability to work independently but also to be a constructive team member

-     Strong time management an communication skills

-     Attention to deal

-     Fluency in English (oral and written)

-     University degree

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