HOPE KUSHNER
MOUNT LAUREL,NJ
Summary
Senior site management associate and central monitor with extensive expertise in clinical research across various therapeutic areas. Proven track record in enhancing trial execution through strategic oversight and stakeholder collaboration. Skilled in risk-based monitoring, ensuring compliance, data integrity, and efficient site management.
Overview
14
14
years of professional experience
Work History
Senior Site Management Associate
ICON PLC
Charlottesville, VA
03.2022 - 06.2026
- Developed strategies to enhance operational efficiency and minimize organizational costs.
- Drafted detailed plans outlining goals, objectives, timelines, milestones, deliverables.
- Established communication as a point of contact between senior leadership team members and other stakeholders.
- Facilitated team communication through the implementation of a structured communication strategy.
- Analyzed data sets to identify trends in customer service and sales.
- Exercised mature judgment and made independent decisions in accordance with established policies, rules and procedures.
- Utilized communication and problem-solving skills to address ongoing issues and resolve conflicts.
- Reviewed, proofread and edited documents to prepare for management signature.
Central Monitoring Associate
ICON PLC
Charlottesville, VA
04.2016 - 02.2022
- Conducted centralized monitoring and risk-based study oversight, identifying compliance concerns, data trends, and site performance issues to optimize trial execution.
- Conducted up to 15 remote monitoring visits per month using EDC, site management dashboards, and vendor systems while serving as the primary point of contact for assigned sites.
- Executed risk-based monitoring activities in alignment with study specific monitoring plans, ensuring data reviews supported protocol objectives and effective study oversight.
- Monitored and analyzed key risk indicators (KRIs) to proactively identify underperforming sites and mitigate risks before data integrity and study timelines were impacted.
- Performed centralized reviews of eCRF data to identify site performance trends, data quality issues, and potential compliance risks in accordance with ICH-GCP guidelines.
- Identified and escalated risks such as missing data, elevated query rates, and protocol deviations, facilitating corrective actions that enhanced site compliance rates.
- Collaborated with site personnel, principal investigators, and CRAs to provide targeted retraining, address root causes, and prevent recurrence of identified issues.
- Fostered communication and stakeholder alignment across study teams, minimizing redundant follow-up activities and enabling more effective site management.
- Facilitated sponsor audits at 2 high-enrolling sites, resulting in highly successful outcomes with only 3 minor findings total.
Clinical Research Assistant
ICON PLC
Charlottesville, VA
09.2015 - 03.2016
- Implemented and monitored clinical trials to ensure sponsor and investigator obligations were met while maintaining compliance and applicable regulatory requirements and ICH-GCP principles.
- Provided clinical trial site oversight to ensure compliance, data quality, participant safety, and inspection readiness while supporting successful study execution in accordance with ICH-GCP and regulatory requirements.
- Escalated site and trial-related issues to clinical trial manager and followed up until resolution to ensure study continuity and compliance.
- Verified that serious adverse events were reported according to trial specifications and ICH-GCP guidelines to support participant safety, regulatory compliance, and accurate safety reporting.
- Performed source document verification and entered queries in the EDC to support data accuracy, completeness, and protocol compliance.
- Reviewed trial master file for missing or outdated documents, collected required records on-site, and filed documents in TMF structure to ensure inspection readiness.
- Confirmed site staff met the qualifications required to perform delegated tasks as well as met training responsibilities prior to the conduct of clinical trial activities.
- Assessed investigative product accountability, dispensation, and compliance at sites to ensure protocol adherence and accurate documentation.
- Prepared trip reports detailing on-site activities and findings, achieving 90 to 95 percent approval in first review cycle.
Clinical Research Coordinator
UNIVERSITY OF PENNSYLVANIA
Philadelphia, PA
10.2012 - 08.2015
- Coordinated patient recruitment and enrollment activities, assessing eligibility and matching participants to appropriate clinical trials, resulting in improved study enrollment outcomes.
- Supported the execution of 20+ oncology clinical research studies through patient recruitment, data management, audit support, and stakeholder collaboration, ensuring compliance with GCP requirements and high-quality study outcomes.
- Managed multiple clinical research studies, ensuring adherence to protocols and enhancing compliance within the research unit.
- Entered and validated protocol-specific clinical data from source documentation, resolved data queries, and partnered with oncologists to maintain data integrity, accuracy, and completeness.
- Developed and maintained paper and electronic case report forms (CRFs) to ensure accurate data collection and compliance with good clinical practice (GCP) standards.
- Prepared reports for internal and external audits, collaborating with principal investigators, sub-investigators, research nurses, and regulatory personnel to resolve audit findings and implement corrective actions.
- Educated surgeons, pathology personnel, and biospecimen teams on protocol-specific requirements for lab intensive studies, streamlining specimen processing and reducing turnaround times for eligibility assessments.
- Designed specimen collection and processing order forms and coordinated timely shipment of biopsy samples to support study requirements.
Education
bachelor's degree - Education
Pennsylvania State University
University Park, PAMasters Degree - Counseling
Pennsylvania State University
University Park, PASkills
- Clinical trial oversight
- Site management
- Risk-based monitoring
- Remote monitoring
- Regulatory compliance
- Protocol compliance
- ICH-GCP
- Source data verification
- Query management
- EDC systems management
- Medidata Rave
- Oracle Clinical
- CTMS management
- eTMF administration
- Inspection preparedness
- Staff training
- Site mentoring
- Team collaboration
- Cross-functional collaboration
- Stakeholder engagement
- Effective communication
- Inspection preparedness
A W A R D S
Recipient of multiple peer and leadership-nominated awards (ICON Inspire) and recognized by sponsors and investigator sites alike for maintaining exceptional professionalism, data clarity, and a calm strategic demeanor across high acuity trials.
Timeline
Senior Site Management Associate
ICON PLC
03.2022 - 06.2026
Central Monitoring Associate
ICON PLC
04.2016 - 02.2022
Clinical Research Assistant
ICON PLC
09.2015 - 03.2016
Clinical Research Coordinator
UNIVERSITY OF PENNSYLVANIA
10.2012 - 08.2015
bachelor's degree - Education
Pennsylvania State University
Masters Degree - Counseling
Pennsylvania State University