Develops/maintains study documents and utilizes PRA systems to manage all aspects of clinical biomedical studies. Provides administrative support to project team members in Clinical Operations and Project Management. Works with the project team to ensure that projects are completed in accordance with the contract and client expectations.
PRA is an Equal Employment Opportunity / Affirmative Action Employer
- Organizes Project Team and Client Meetings including scheduling, meeting materials, binders, agendas and meeting minutes etc.
- Maintains and distributes project documents including but not limited to protocol/IDB, project plan, study timelines, Change in Scope Logs directed by Project Team (PM/PD/CTM/CRA or IHCRA) .
- Generates and maintains organizational charts, team calendar, newsletters, mass mailings, project specific information including but not limited to: process flow charts, contact lists, holiday lists, study website, mailing labels.
- Manages project reporting (internal and client reporting), generates and reviews for accuracy crystal reports to facilitate project status and financial reporting (e.g. P&L, burn rate, project time dump, study status summary and ART based reports).
- Manages Investigator payment process and maintains PRA systems to ensure accurate and timely payments and to support financial reconciliation.
- Facilitates investigator contracts process using appropriate PRA systems to track status of contracts and amendments (s). Has oversight of purchase order process including raising and processing purchase orders and processing study invoices. System updates including CTMS input and queries.
- Assembles and dispatches on-site investigator, pharmacy sites files (Master and Local).
- Populates regulatory document templates.
- Organizes and tracks translations following PRA systems/processes.
- Routes study documents to Document Management.
- Ensures documents within eTMF2 comply with filing/naming guidelines and have the correct status. Tracks, dispatches and maintains study supplies following PRA process.
- Creates and maintains essential documents packages including workflow processing.
- Supports investigational sites
· An undergraduate degree or its international equivalent in business, finance or health sciences from an accredited institution, or equivalent work experience.
· Proven ability to use all MS Office suite or applications including Word, Excel, Access, PowerPoint.
· Read, write and speak fluent English; fluent in host country language
- Familiarity with medical terminology
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