Senior Centralized Study Associate
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
We are looking for a Senior Centralized Study Associate to join our team in Bulgaria.
Summary of Responsibilities:
- Manage clinical systems and access management.
- Manage study documents and support eTMF management.
- Maintain study databases (CTMS IWRS EDC etc.)
- Support study team in data review and support activities.
- Track and follow up with CRAs for outstanding issues.
- Support in generating the study specific reports.
- Manage internal/external communications.
- Manage study payments (Site and Vendor).
- Generate Study Reports and perform analysis.
- Perform Access management on applicable study systems.
- Perform study system set up on new awarded studies.
- CTMS compliance management
- Manage project training compliance
Qualifications (Minimum Required):
- University/College Degree (Life Science preferred) or certification in an allied health profession from an appropriate accredited institution (Ex. Nursing certification Medical or laboratory technology).
- 3-5 years of work experience in clinical research including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Learn more about our EEO & Accommodations request here.
Required Experience:
Senior IC
Key Skills
- Business Development
- Organizational Management
- GAAP
- Accounting
- Analysis Skills
- Meeting Facilitation
- Microsoft Powerpoint
- Investment Banking
- Microsoft Excel
- Private equity
- Financial Modeling
- Writing Skills
