Medicines360

Clinical Research

• Lead day-to-day clinical operations across the study lifecycle, including feasibility, start-up, conduct, monitoring, closeout, and archival
• Independently manage assigned studies, sub-studies, countries, regions, sites, or functional workstreams
• Serve as primary contact for investigators and site staff; drive site activation, enrollment, and retention
• Coordinate site clinical trial agreements, budgets, and payments
• Plan, conduct, document, and follow up on site qualification, initiation, interim monitoring, remote monitoring, and closeout visits
• Co-monitor with CRO CRAs and verify resolution of findings and action items
• Assess site performance, protocol compliance, informed consent, participant safety, source documentation, product accountability, data quality, and regulatory file completeness
• Coordinate CROs, laboratories, imaging and diagnostic vendors, technology providers, depots, and other service providers
• Coordinate country- and site-level requirements, ethics and regulatory submissions, translations, import/export needs, and global study logistics
• Provide input to feasibility, site selection, enrollment projections, timelines, and risk assessments
• Draft, review, and maintain clinical documents and study materials
• Maintain trial master files and investigator site files and support inspection readiness
• Coordinate investigational product, device, IVD kit, specimen, and ancillary supply logistics
• Support study-specific training and present at investigator and internal study meetings
• Partner cross-functionally to resolve protocol, safety, data, product, and operational issues
• Review enrollment, retention, monitoring metrics, data listings, queries, deviations, safety information, complaints, deficiencies, and study trends
• Maintain study trackers and prepare status reports, enrollment reports, and monitoring dashboards
• Support regulatory submissions, audits, inspections, responses, CAPAs, and commitments
• Contribute to clinical SOPs, templates, tools, and process improvements
• Provide mentoring, co-monitoring, quality review, and technical guidance to less experienced CRAs and study team members

Explore Senior Clinical Research Associate at Medicines360. Review requirements and application details.

Senior Clinical Research Associate

Compliance

• Develop and execute global regulatory strategies for complex regulatory projects involving cross-functional teams and external partners
• Coordinate cross-functional teams to deliver high-quality regulatory submissions on project targets
• Oversee preparation, review, and approval of clinical investigation applications, marketing applications, post-marketing reports, and regulatory authority interaction requests
• Lead regulatory assessments for change management, including data review, reporting strategies, and risk assessment
• Ensure compliance of product labeling for investigational use and commercialization
• Provide regulatory guidance on clinical development programs, CMC strategies, medical device development, DHFs, and promotional materials
• Author regulatory documentation and leverage subject matter experts as needed
• Ensure archival of regulatory files and records
• Manage relationships with regulatory CROs, consultants, and other external partners
• Monitor, interpret, and disseminate regulatory legislation, guidance, practices, and women’s health industry trends
• Contribute to clinical, quality, and regulatory SOP development and approval
• Perform regulatory due diligence for new product candidates
• Lead cross-functional regulatory inspection teams and participate as regulatory lead
• Manage and mentor regulatory personnel
• Oversee pharmacovigilance risk management plans, CCDS, and product labeling
• Serve as Veeva RIM system administrator and subject matter expert

Explore Director, Regulatory Affairs at Medicines360. Review requirements and application details.

Open roles

Senior Clinical Research Associate

Director, Regulatory Affairs