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Clinical Trial Project Coordinator Specialist
hace 1 mes
The Clinical Trial Project Coordinator Specialist will play a vital role in ensuring the smooth execution of clinical trials within our organization. This individual will be responsible for performing department, internal, country, and investigator file reviews as assigned, documenting findings in appropriate systems, and ensuring allocated tasks are completed on time, within budget, and to a high-quality standard.
Key Responsibilities:- Project Coordination: The successful candidate will coordinate project-specific activities, including but not limited to: study team lists, tracking of project-specific training requirements, system access management, and tracking of project-level activity plans in appropriate systems.
- System Support: Provide system support for projects, including but not limited to: GoBalto & eTMF.
- RBM Activities: Support Risk-Based Monitoring (RBM) activities, ensuring that all necessary steps are taken to mitigate risks and ensure compliance with regulatory requirements.
- Administrative Tasks: Perform administrative tasks on assigned trials, including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Scheduling Meetings: Coordinate scheduling of client and/or internal meetings, ensuring that all necessary parties are informed and prepared.
- Regulatory Compliance: Review and track local regulatory documents, ensuring that all necessary steps are taken to maintain compliance with regulatory requirements.
- Document Transmission: Transmit documents to clients and centralized IRB/IEC, ensuring that all necessary documentation is complete and accurate.
- Metric Analysis: Analyze and reconcile study metrics and findings reports, identifying areas for improvement and implementing corrective actions as necessary.
- Education: Bachelor's degree or equivalent experience.
- Skills: Excellent communication and organizational skills, proficiency in Microsoft Office Suite, experience with project management tools and systems.
- Experience: At least 2 years of experience in a related field, preferably in clinical trials or project coordination.
This position offers an estimated salary range of $65,000 - $80,000 per year, depending on location and experience. Benefits include health insurance, retirement plan, paid time off, and opportunities for professional growth and development.
