Clinical Trial Associate

For our client in ROTKREUZ we are looking for a CLINICAL TRIAL ASSOCIATE for a 12-MONTH CONTRACT.

DURATION: 2018-01-01 TILL 2018-12-31

LOCATION: ROTKREUZ

WORKLOAD: 100%

DUTIES:

SUBMISSIONS AND DOCUMENTATIONS:

. Liaises with clinical team to help compile initial and amended regulatory document package for the central and local IRB/IECs and sites.
. Collaborates with teams to ensure parallel HA and IRB/IECs submissions, if needed
. Tracks the status of regulatory readiness and alert the Clinical Study Manager and MA appropriately to any issues/challenges in getting sites ready.
. If relevant, works with translating agencies to ensure translation of relevant clinical study documents.
. Ensures appropriate versions of legal documents (CTA and other agreements) are used and ensure database is kept current. In collaboration with local clinical team responsible for contract management with investigators, vendors. Liaise with legal to track and process agreements
. Responsible for scanning essential trial related documents/communications in relevant systems
. In collaboration with CSMs and CRAs, responsible for the set-up and maintenance of country and site specific TMFs continuously up to date in accordance with regulatory and Clinical Trial Supplies requirements
. Assists local trial team with the creation, ordering, and mailing of any study tools including recruitment materials as well as newsletters, blast email communications, blast faxes etc
. Supports local trial team with ordering/tracking/coordinating shipment of any necessary trials supplies

FINANCE:

. Provides support to CSM for trial budget planning, forecast and accounting
. Tracks, processes and releases milestone payments to study sites in collaboration with local study team and finance
. Tracks, processes and releases payments to vendors in collaboration with local study team and finance
. In collaboration with local finance supports the refund process

General
. Ensures that all reporting systems, are kept up to date and reports any discrepancies to the local trial team throughout trial conduct
. May assist with endpoint tracking or other specific tracking needs of a trial
. May assist with setting up webcasts, TCs or other meeting formats
. Supports local trial team with Investigator Meeting organization

REQUIREMENTS:
- Commercial Training or Studies or equivalent
- Experience in Pharma environment
- Experience stated in the job description

For further information please cnotact Beata Arciszewska: (see below)