The Director of Research Site Partnerships serves as the executive relationship owner for a portfolio of oncology research sites to drive engagement and clinical trial enrollment. They are responsible for aligning enterprise strategy with site goals, analyzing performance trends, and leading sites through change and transformation.
The Medical Writer is responsible for researching, writing, and editing clinical documents such as protocols and study reports for regulatory submissions. They also serve as the primary point of contact for document writing and ensure quality control through editing and version management.
The Regulatory Affairs Coordinator manages and plans regulatory compliance for industry sponsors and clinical sites while ensuring adherence to FDA and GCP standards. They are responsible for maintaining document management systems, processing electronic signatures, and providing regulatory support for clinical operations.
The specialist manages and plans regulatory affairs compliance for clinical research sites and industry sponsors. They are responsible for maintaining FDA and GCP documentation, processing IRB submissions, and ensuring adherence to SOPs.
The Research Quality Manager is responsible for implementing quality assurance programs and managing support visits at investigative sites. They also assist with external audits, monitor quality indicators using a risk-based approach, and provide routine quality support to ensure regulatory compliance.
The Manager of Research Regulatory Affairs oversees regulatory operations, ensures compliance with FDA and GCP guidelines, and manages the regulatory department. They are responsible for developing regulatory strategies, managing relationships with industry sponsors, and mentoring regulatory staff.
