Responsible for providing operational and program level support for several Phase I/II clinical trials under the leadership of the assigned Lead CTL. This support includes planning, set-up, maintenance and closeout of trials as applicable.
1.Support TCO Lead CTL and CTLs in group in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of related study documents (eg sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
2.Support CTLs by setting up and maintaining appropriate study tracking forms including:
enrollment log/trial allocations forms, site and vendor contact lists, drug shipping logs, set up and maintenance of team membership and contact lists.
3.Support CTLs in managing interactions with relevant functions including Drug Supply Management and Novartis local organizations (CPOs). Support CTL with all US drug supply shipping (initial and re-supply) to local CPO and all US sites to ensure timely SIV and uninterrupted patient treatment. Function as the liaison with US local depot to ensure drug delivery and relabeling occur in a timely fashion and track all drug at the central hubs. Support CTLs in all drug tracking (central hubs, local CPOs and sites) to ensure adequate supply, monitor expiration dates and assist in relabeling as appropriate. Support CTL in tracking all batch numbers used throughout trials and assist with preparation of appropriate CSR appendices.
4.Provide vendor and budgets tracking and support. Manage and track US invoices for third party vendors.
5.Associates based in TCO Shanghai, support local CTA submission including validation of translation of protocols, amendments, ICFs, IBs etc. for TCO trials with sites in China.
6.Supports the Lead CTL or CTLs as the local trial leader (LTL) for US operational activities including working closely with US Clinical Operations for US study start up meetings and trial agreements in addition to all other US based study start-up activities working closely with the US Clin Ops Oncology to ensure timely Study Initiations and VDR (Verification Document Receipt) support; Updates Global ICF templates for all trials to ensure appropriate Novartis US standard language incorporated at time of package release while acting as the US liaison with Novartis Legal and the US sites through IRB approval process.
7.Set up and maintain eTMF tracker in CREDI for all studies. Provide support to CTL to ensure timely completion of eTMF tracker for CSR.
8.Support CTL in delegated aspects of trial data analysis and reporting, including attendance at all relevant study meetings (i.e. CTT and dose escalation meetings). Provide support in meeting scheduling and distribution of meeting agendas/minutes.
9.Assist with data monitoring such as tracking/filing of protocol deviations, generating data listings and database metrics.
10.Assist CTL with preparation and distribution of study tools needed at study start up and throughout trial as appropriate.
11.Support the Lead CTL and CTLs for both PK and biomarker sample tracking in collaboration with the Clinical IT Specialist and act as a liaison with sites for sample shipment, sample reconciliation and associated logistics
12.Support Lead CTL and CTLs for tracking molecular screening samples and data as required.
13.Support the Lead CTL and CTLs for imaging tracking and act as a liaison with sites for imaging deliverables, image reconciliation and associated logistics.
Clinical Project Associate (CPA)