Clinical Project Associate

7 months ago

Reading, United Kingdom ICON Full time

As a Clinical Project Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The CPA will interact on a global scale within the study team and clinical team. The CPA sphere of influence and communication will include the Global Clinical Lead, the Clinical Project Manager, the Study Manager(s), the Study Lead Monitor(s), Study Data Manager, Study Medical Expert, Study Statistician, country teams, the IxRS & Medication Manager (IMM), Legal, Procurement, Regulatory Affairs, Controlling, Accounting, Pharmacovigilance, Insurance and other study team members (globally and locally). The CPA will additionally liaise with external suppliers globally.
- Support global study team by completing delegated study tasks.
- Coordinate administrative tasks and logistic support throughout the study, audit and regulatoryinspections according to company policy and SOPs.
- Coordinate project and/or study material preparation and study communication internally and/or with external vendors such as:
Manage and maintain study information and documents as agreed with study team.Set-up and maintain study specific working areas and internet-based forums, support Recruitment and Retention team in preparing external study websites, social media channels etc.

Create and send communication materials to country teams (e.g., Newsletters, study document updates).

Coordinate communication of project/study status to various levels of management

Coordinate investigator and CRA training material preparation activities, provide technical support, ensure delivery of training materials in due time, make material available.

Manage vendor system access (user account) activities for internal and external users. Ensure account creation during study start-up and conduct, conduct periodic checks of valid user accounts, and ensure deactivation of unnecessary user accounts.
- Coordinate logistics (orders and shipments) of trial supplies for sites (e.g. eCOA device orders and shipments, laboratory kits and medical equipment).
- In cooperation with other global study team members prepare essential clinical trial documentation and distribute to countries.
- Obtain study insurance documentation for different countries at the study start and maintain insurance documentation during the study, communicate with insurance group (for internal and outsourced studies) as delegated by StM
- Collect essential documents as needed.
- Maintain operational tracking and reporting systems and tools; for example, YourDOCs (invoices), IRIS (study level issue&action tracking), Veeva Vault Clinical/IMPACT, Veeva eTMF, CART, external vendor systems etc.
- Have oversight of site, country and study level CTMS entries.
- Track study progress and run progress reports for StM/SLM through following up with other team members and develop update reports for StM/SLM.
- Run oversight reports related to outsourced studies.
- Lead the practical arrangements coordination of internal and external meetings (scheduling, drafting agenda and/or presentations, taking care of practical arrangements, writing meeting minutes and tracking action items) for the Clinical Team and Study Team kick-off meetings, study Start-up Camp, kick-off meetings with external vendors, Clinical Team meetings, global core Study Team meetings, Country Calls arranged by SLMs as well as global and regional investigator meetings and global/regional monitor training meetings in collaboration with IMEX group (if applicable) and advisory committee meetings as requested by CPM/GCL.
- Ensure the availability, quality, and completeness of the clinical study documents in the Trial Master File to enable final compilation of the documents for marketing authorization submissions of new medications and medical devices.
- Upload and maintain global documentation in eTMF (e.g. meeting minutes, eCOA documentation).
- Coordinate the functional (global) milestone related quality and completeness check review of eTMF.
- Run oversight reports and do random spot checks for eTMF completeness and quality.
- Act as a point of contact for SSU/QC Specialists, CLMs and global core Study Team members for study specific eTMF filing issues.
- Support outsourced studies under COSMOS as interface between Medical Affairs, CRO and Resource Management.
- Contribute to departmental / company initiatives and special projects. Provide expertise and support project planning, project management and implementation of functional initiatives to improve processes.
- Bachelor’s degree or equivalent relevant experience
- Experience in the healthcare field, pharmaceutical industry or clinical research / development or administrative activities.

**Why ICON?**

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our

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