Howard Abegesah

Clinical Trial Manager with 8+ years of experience overseeing oncology and immunohistochemistry trials across pharma, academic, and DoD-affiliated environments. Skilled in study start-up, sponsor/CRO communication, regulatory document management, and ICH-GCP/ALCOA++ compliance. Experienced coordinating cross-functional trial operations across EDC/EMR platforms (RAVE, EPIC, OnCore, REDCap) and managing site-level quality, budgeting, and adverse event reporting to ensure on-time, inspection-ready execution.

Clinical Research Coordinator, Oncology Melanoma Phase II Efficacious Study - Inova Health Systems - Fairfax, VA

(2022 - 2023)

• Managed site-level trial operations across 4 concurrent trials, overseeing participant incentive tracking and site overhead budgeting through the OnCore platform to prevent financial discrepancies throughout each longitudinal study.
• Conducted quality review meetings to align investigator site files with 21 CFR (50, 76, 312, 812) and 45 CFR (46) regulatory standards, reducing site-level deviations by 15 identified during third-party audits.
• Reported Adverse Events, Serious Adverse Events, and Suspected Unexpected Serious Adverse Events via MedDRA to sponsors and review panels in a timely manner, protecting participants from ongoing trial-related and unrelated risks.
• Screened patients for protocol eligibility and led informed consent discussions in accordance with HIPAA and ICH-GCP guidelines, maintaining patient-centric compliance throughout the study.

Clinical Research Coordinator, Community Research Program — HIV and STI Detailing Intervention - Johns Hopkins University - Baltimore, MD

(2013 - 2015)

• Evaluated site feasibility and healthcare provider readiness during initiation visits, cross-referencing interventional survey data with pilot meta-data analysis to select qualified HCPs and point-of-care sites, enrolling 10 providers per week.
• Implemented a REDCap data monitoring template aligned to site personnel and client infrastructure, enabling real-time data streaming to support a risk-based monitoring approach.
• Managed site regulatory packages for IRB submissions and conducted 15 quality assurance audits per quarter, removing field monitoring errors and resolving query and questionnaire discrepancies ahead of inspections.
• Facilitated Sponsor-Investigator-Patient ad hoc meetings with informed consent mock trials to verify QA/QC algorithms and advance enrollment, participant compliance, and data integrity.

Associate Research Scientist, Department of Defense Immunohistochemistry and ADME - Henry Jackson Foundation - Bethesda, MD

(2016 - 2017)

• Advanced an in vivo comparative animal model pharmacokinetic R&D study to de facto phase 0 in-human trial arms, providing escalation dosage ranges demonstrating ADME effectiveness.
• Enhanced protein batch validation systems including Gel Electrophoresis, PCR, BCA assay kits, and ELISA Biotinylation protocols, establishing tightened critical parameters and removing toxic contaminants in facultative aerobic hoods.
• Extended a comprehensive biomarker panel from 30 markers to include brain memory cells and pyramidal GDNF and BDNF, augmenting a Mouse CYT ELISA Spot into a prophylactic gamma radiation pharmacodynamics study.
• Logged discrepancies into computerized data repositories to capture LIMS-generated queries and errors, configuring specificity and accuracy of resolution outputs.

Laboratory Specialist and Environmental Monitor, Multiplex Biodefense - GenArraytion Inc. - Rockville, MD

(2011 - 2013)

• Lyophilized proteins and separated supernatant from DNA samples, producing stabilized templates for multiplex platform assay reconstitution using precise primer, dNTP, and stock solution aliquots.
• Expanded the Genetic Bank Output database using a multi-bead chromatography platform and ABI 7000, widening the pool of virulent bacterial and viral strands for environmental quality control screening.
• Piloted throughput validation techniques with QA manual reviews to optimize real-time PCR, western blot, and multi-flex bioassays for diagnostic and veterinary vector-borne pathogen tracking.

Private Chef - Howie's Kitchen - Beltsville, MD

(2017)

• Delivered in-home private chef services featuring culturally diverse cuisine tailored to client expectations.
• Applied food safety procedures and aseptic techniques to sanitize and prepare kitchen environments.

Postgraduate Certification - Clinical Trial Management Program - Virtual Parexel Academy (2026)

Bachelor of Science - Biology - Virginia Military Institute (2010)