Alvina Acquaye-Mallory
Glen Allen,VA
Summary
Results-driven clinical research professional with over 17 years of experience managing global oncology trials and observational studies, specializing in rare CNS tumors. Proven track record in using operational expertise to drive vendor management, enrollment optimization (213% increase), regulatory compliance (GCP, FDA, ICH) and continuous improvement initiatives. Expert in leading cross-functional teams to deliver impactful real-world evidence generation across therapeutic areas.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Program Manager/Psychosocial Behavioral Specialist
National Institutes of Health
10.2019 - Current
- Lead in neuro-oncology trial operations, overseeing planning, setup, managing regulatory submissions, and close-out with cross-functional teams, contributing to observational research studies spanning multiple therapeutic areas (pain, mental health, CNS tumors) achieving 86-96% patient-reported outcome measure completions.
- Lead in protocol development and design, study timelines, stakeholder engagement plan, and continuous process improvement for psychosocial observational research (wearable device, VR), presenting study details at Site Initiation Visits (SIVs), resulting in 25+ peer-reviewed manuscripts, 40+ peer reviewed abstracts.
- Increase patient recruitment and retention in a global CNS Natural History study by 213% achieving through optimized recruitment forecasting strategies.
- Develop 10+ Standard Operating Procedures (SOPs) using tailored process design for real-world evidence (RWE) studies, enhancing study process, audit readiness and regulatory compliance (GCP, ICH, FDA).
- Collaborate with vendors on risk mitigation strategies for observational research portfolios for timely reporting and study execution.
- Mentor 5 junior researchers for career development, delivering training modules, leading to initiatives on data quality and presentation of clinical study reports (CSRs) to lead investigators.
- Negotiate cost-effective vendor contracts, reducing supply costs while optimizing lab operations and resource allocation.
- Orchestrate regular cross-functional team meetings, implementing a structured progress tracking system, resulting in improved study milestone achievement and enhanced interdepartmental collaboration.
- Implement risk management strategies, identifying and mitigating potential issues to maintain project timelines and quality across the study lifecycle.
Bio-Behavioral Research Associate
Columbus Technologies and Services Inc.
10.2016 - 10.2019
- Enhanced trial recruitment by leveraging electronic health records (EHRs) databases for real-world data collection methodologies in observational studies, increasing participation rates.
- Analyzed clinical trial data using SPSS and MAXQDA, refining study design data collection operational strategies.
- Developed psychosocial protocols through cross-functional coordination, improving patient and retention in real-world evidence (RWE) trial outcomes.
Research Associate
UT Health Science Center at Houston
05.2015 - 09.2016
- Managed neuro-oncology protocol plan, optimizing workflows and ensuring GCP compliance to meet study timelines.
- Prepared clinical study reports (CSRs) by synthesizing trial data and insights, supporting high-impact publications.
- Directed staff in protocol adherence through risk identification, enhancing trial efficiency and data quality.
Counseling Associate
MD Anderson Cancer Center
11.2008 - 05.2015
- Coordinated neuro-oncology studies, implementing psychosocial support strategies to improve protocol compliance and patient retention.
- Oversaw patient accrual and data audits through team training, ensuring timely and accurate trial execution.
- Resolved clinical queries by monitoring activities and regulatory standards, maintaining consistent adherence.
- Managed study databases for observational trials (wearables, patient-reported outcomes etc), conducting quality audits and compliance checks to ensure protocol adherence and data integrity.
- Trained personnel in recruitment and data management, boosting team performance metrics.
- Contributed operational feasibility input to research protocols, enhancing trial readiness and execution.
Education
Master of Science - Counseling
University of Houston-Clear Lake
Bachelor of Science - Psychology
University of Houston
Houston, TXSkills
- Oncology Clinical Research
- Clinical Operations
- Global Trial Leadership
- Regulatory Compliance (GCP, ICH, FDA)
- Enrollment Optimization
- Operational Process Improvement
- Vendor & Stakeholder Management
- Team Development & Mentorship
- Cross-functional Collaboration
Certification
Human Research Protection Program Training (CITI), Good Clinical Practice (GCP) Certification
Skills
Clinical Trial Management: C3D, Labmatrix, Redcap, Trial Master File (TMF) Oversight
Regulatory & Compliance: GCP, ICH, FDA Compliance, Serious Adverse Events (SAE) Reporting
Leadership & Collaboration: Team Supervision, Vendor Coordination
Data Analysis & Visualization: IBM SPSS Statistics, MAXQDA, GraphPad, Surveymonkey
Interpersonal Skills: Stakeholder Engagement, Patient-Centric Solutions, Problem-Solving, Communicate effectively
Timeline
Program Manager/Psychosocial Behavioral Specialist
National Institutes of Health
10.2019 - Current
Bio-Behavioral Research Associate
Columbus Technologies and Services Inc.
10.2016 - 10.2019
Research Associate
UT Health Science Center at Houston
05.2015 - 09.2016
Counseling Associate
MD Anderson Cancer Center
11.2008 - 05.2015
Master of Science - Counseling
University of Houston-Clear Lake
Bachelor of Science - Psychology
University of Houston
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