Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
The Project Administrator possesses a basic understanding of clinical research and demonstrates effective communication skills. The Project Administrator is responsible for supporting members of the project team (i.e., Project Specialist (PS), Associate Project Manager (APM), Project Manager (PM), Clinical Manager (CM), and other functional leads), to perform and execute all country specific administrative tasks associated with a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. Administrative tasks may include but are not limited to creating, maintaining and updating site contact information in clinical trial management systems, distributing current contact information to applicable vendors, updating and maintaining project system access for all team members, management, coordination and distribution of site shipments, assisting with eTMF reconciliation, following up with team members on various deliverables/metrics, and other administrative tasks as necessary.
As a Project Administrator you'll be accountable for:
Overall Project Delivery: Assist in overall Project Delivery through coordination of efforts assigned to entire project team, (may include Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety). May assist with overall study team tracking, project system access for team members, creation and maintenance of team member and site contact information within specified system(s), overall management of site shipments (site and patient materials) in accordance with study milestones, and study documentation (TMF), as appropriate.
Study Deliverable Tracking: Assist in the collection of information as it pertains to functional department deliverables and milestones through clear communication with the functional leads and use of various study databases.
Communications: Under supervision of PM and CM (and/or APM or PS where appropriate), initiate team communications and documentation internally and externally. Maintain internal and external (Client and site) project team contact lists.
Audit Readiness and Trial Master File: May assist the PS with ensuring assigned projects are audit ready; i.e., project tasks are completed in accordance with project plans and SOPs and are filed to TMF, TMF reconciliation as appropriate.
Study Team Training: May assist in coordination of team trainings or meeting presentations, and may maintain the study training matrix. Assists the team (i.e., PS, APM, PM, CM, other functional leads) to ensure completion and proper documentation of study specific training requirements.
Plans and Trackers: May assist in customizing project templates, and developing and maintaining tracking tools for project documents/deliverables and monthly progress reports.
Study System Set-up and Maintenance: Manages the creation of required project systems, SOP indexes, and study team lists. Manages study team and site contact lists, system access requests, and e-mail distribution lists.
Finance Management - Grant/Vendor Payments: Manages the timely approval and tracking of pass-through invoices in accordance with the executed Clinical Trial Agreements. Assists with tracking supplies, invoices, and budgets relating to vendor management, as appropriate.
As a Project Administrator you'll need this background to be considered:
Bachelor degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field, or equivalent combination of education, training and experience
Ideally some clinical research experience, or demonstrated experience executing administrative tasks in a fast-paced corporate environment
Project management or Clinical Operations support experience within CRO or pharmaceutical industry preferred
Experience gained as a Study Co-ordinator in a hospital environment may also be considered
Basic knowledge of ICH/GCP regulations
Basic knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
Basic knowledge of project management terminology and guidelines preferred
Strong computer skills in MS Office