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 Lead Solution Architect is responsible for designing, building, and managing the organization's data infrastructure to ensure it is scalable, secure, and aligned with business goals. This role involves developing data strategies, implementing data governance policies, and integrating AI models with existing data systems.
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 Product Analyst II will bridge the gap between business and IT teams to define requirements and lead digital transformation initiatives. This role involves identifying AI and automation opportunities, developing prototypes, and ensuring solutions align with regulatory and data standards.
The Clinical Trial Central Screener will perform centralized clinical support for patient screening, including clinical trial patient identification and remote chart review. They will also serve as a liaison between network sites and the operations team to facilitate precision medicine software utilization and process improvements.
The Lead Intelligent Solutions Engineer will design, build, and scale LLM- and agent-based automation solutions while owning the end-to-end architecture and technical delivery. This role involves evangelizing AI capabilities across the business and translating complex problems into production-ready, high-impact intelligent workflows.
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 Payment Reimbursement Analyst manages the end-to-end vendor invoice process, including review, reconciliation, and payment processing. This role acts as a liaison between vendors and internal departments to resolve billing discrepancies and ensure compliance with contractual and regulatory standards.
The Study Activation Specialist manages the startup activities of clinical trials and serves as the primary point of contact during feasibility, planning, and implementation. They are responsible for building relationships with sponsors and CROs while tracking site metrics to facilitate the study activation process.
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.
The Senior Manager of Research Regulatory Affairs oversees regulatory operations, including trial start-up, maintenance, safety, and conflict of interest compliance. They lead cross-functional teams to streamline processes, manage relationships with industry partners and the FDA, and ensure adherence to clinical research standards.
The Application Engineer II provides technical support and administration for enterprise applications, including configuring, testing, and troubleshooting system solutions. They also manage integrations, triage user incidents, and collaborate with cross-functional teams to ensure operational efficiency and compliance.
The IT Quality Control Specialist oversees software, process, and data integrity validation to ensure compliance with GxP and regulatory requirements. They provide guidance to operational teams and review validation life cycle documentation including system plans and risk management reports.
