Role OverviewLead and coordinate clinical research efforts following product release to evaluate real-world safety and performance. This position plays a key role in maintaining regulatory compliance, managing study logistics, and supporting data quality across clinical initiatives.
Key Responsibilities
- Develop and update study-related materials, including training content and procedural documentation
- Deliver training sessions for clinical site personnel and internal teams
- Support site activation processes, including preparation of essential start-up documents
- Establish and manage tracking systems to monitor study progress and milestones
- Contribute to the development of reports, regulatory filings, scientific publications, and presentations
- Support budget development and project planning activities
- Identify potential quality concerns and implement corrective actions
- Coordinate meetings, calls, and training events as needed
- Review and assist in the analysis of clinical data
- Manage resolution of site-level issues in a timely manner
- Supervise tasks performed by supporting staff, ensuring adherence to protocols and regulations
- Apply standard operating procedures and study guidelines to daily activities
- Engage in initiatives to improve clinical processes and participate in ongoing professional development
Qualifications
Required
- Bachelor’s degree in a relevant field
- Minimum of four years of experience in clinical research; a Master’s degree may count toward one year of experience
Preferred
- Familiarity with Good Clinical Practice (GCP) and regulatory standards for clinical investigations
- Strong understanding of medical terminology
