> Clinical Research & Trial ManagementClinical trial project management (Phase I-IV)
Protocol development & implementation
Regulatory compliance (FDA, ICH-GCP, IRB/IEC)
Monitoring subject safety and AE/SAE reporting
Informed consent process oversight
> Participant Recruitment & RetentionRecruitment strategy development and execution
Patient screening and eligibility assessment
Community outreach and engagement for diverse populations
Relationship management with clinical sites and referral sources
Enrollment tracking and forecasting
> Safety Monitoring & Follow-UpSafety data collection and adverse event documentation
Coordination of post-treatment follow-up visits
Collaboration with medical monitors and safety committees
Ensuring timely SAE reconciliation and reporting
> Project Coordination & CommunicationCross-functional team leadership (clinical ops, data, regulatory)
Stakeholder communication and status reporting
Vendor management (CROs, labs, central IRBs)
Timeline and milestone tracking
Budget oversight and resource allocation
> Soft Skills & CompetenciesStrategic problem-solving
Excellent written and verbal communication
Strong organizational and multitasking abilities
Adaptability in fast-paced clinical environments
Cultural competency and patient-centered approach
Verified
