Fortrea is committed to advancing pharmaceutical, biotechnology, and medical device development through its innovative solutions. With operations spanning over 90 countries and expertise in more than 20 therapeutic areas, Fortrea is transforming clinical trials and healthcare delivery. They offer a collaborative environment for personal growth and professional excellence, fostering creativity and innovation at every stage of the development process.
Job Responsibilities for Centralized Study Specialist I
This role involves supporting the clinical study process across multiple dimensions to ensure successful execution. Below are the key responsibilities:
1. Managing Clinical Systems and Documentation
- Manage and maintain study databases (CTMS, IWRS, EDC)
- Organize and support the eTMF (electronic Trial Master File) management
- Track and follow up with Clinical Research Associates (CRAs) for outstanding issues
- Assist with internal/external communications and training compliance for study teams
2. Data Review and Monitoring
- Support resolution of data management queries
- Generate study-specific reports and dashboards
- Perform Associate Lead/Lead roles on assigned projects
- Review and validate Investigator Packages, Informed Consent Forms, and recruiting materials for regulatory compliance
3. Site and Vendor Management
- Manage site payments, including reconciliation and vendor payments
- Assist in contracts and budgets for investigative sites
- Help prepare new investigator submission packages for regulatory submissions
4. Quality and Process Improvement
- Perform quality checks and escalate issues where necessary
- Identify and implement process improvements to enhance study deliverables
- Support the implementation of monitoring tools for studies
5. Training and Mentorship
- Mentor and train junior team members
- Collaborate with global stakeholders to streamline clinical processes
Qualifications
The ideal candidate for the Centralized Study Specialist I role must meet the following qualifications:
- Educational Background: A degree in Life Sciences, Pharmacy, or a related field
- Work Experience: Prior experience in clinical trials or data management is preferred
- Familiarity with Good Clinical Practice (GCP) guidelines and regulatory requirements
Key Skills and Competencies
- Strong knowledge of clinical systems (CTMS, IWRS, EDC) and eTMF management
- Excellent communication and interpersonal skills to coordinate with global teams
- Ability to manage multiple studies and prioritize tasks effectively
- Problem-solving and analytical thinking to identify opportunities for process improvements
- Proficiency in report generation and monitoring metrics
- Attention to detail for reviewing documents and ensuring regulatory compliance
