Anika Abrams

• Managed high-volume medication inventory, ensuring 100% accuracy in the receipt, storage, and dispensation of controlled and non-controlled substances.
• Performed pharmaceutical calculations and dose verifications, ensuring patient safety through the double-check of high-risk prescriptions.
• Monitored for Adverse Drug Reactions (ADRs) and contraindications, proactively identifying safety concerns and escalating them to the Pharmacist-in-Charge.
• Maintained strict cold-chain integrity for temperature-sensitive biologics and medications, utilizing digital monitoring systems to prevent and document temperature excursions.
• Audited inventory logs and dispensation records, maintaining a "Ready-to-Inspect" environment for state board and internal quality assurance reviews.
• Enforced strict HIPAA compliance, safeguarding protected health information (PHI) and maintaining the level of confidentiality required in clinical trial settings.
• Navigated complex insurance and regulatory frameworks, reconciling documentation discrepancies to ensure data accuracy and seamless patient care.
• Educated patients on medication adherence, demonstrating the clear, concise communication style necessary for executing the Informed Consent process in research.
• Inventory Accountability & Chain of Custody
• Regulatory Compliance & Pharmacovigilance

Site Management & Quality Assurance

• Spearheaded multi-site operations for a high-complexity translational study, standardizing SOPs across locations to ensure 100% data consistency and protocol adherence.
• Performed internal quality audits of Essential Documents and Trial Master Files (TMF), identifying and resolving documentation gaps to maintain audit readiness for FDA/sponsor inspections.
• Executed rigorous Source Data Verification (SDV), reconciling medical records with EDC entries and resolving [Percentage]% of data queries within [Number] business days.
• Served as the primary liaison for Sponsor CRAs (including interactions with ReAlta Life Sciences), facilitating monitoring visits and ensuring prompt resolution of site-level action items.

Clinical Operations & Patient Safety

• Managed recruitment and informed consent for vulnerable preterm neonatal populations, navigating complex ethical requirements and maintaining an 89% participant retention rate.
• Oversaw Serious Adverse Event (SAE) reporting and protocol deviations, ensuring accurate documentation and IRB notification within required 24-hour windows.
• Collaborated with a multidisciplinary team of neonatologists, laboratory scientists, and data managers to translate clinical variables into measurable exposure-outcome models.

Translational Research & Laboratory Leadership

• Directed the "Animal Arm" of the study, managing tissue collection for downstream RNA/protein analysis in compliance with IACUC and biosafety protocols.
• Led biospecimen lifecycle management, overseeing the collection, flash-freezing, processing, and IATA-compliant shipment of neonatal and animal samples.
• Performed precision molecular assays to identify biomarkers of exposure, including qPCR, RT-PCR, Western blotting, MDA assays, and ELISA.
• Supervised and trained research personnel on specialized specimen handling, molecular assay protocols, and Good Documentation Practices (GDP).

Regulatory & Scientific Contribution

• Managed the lifecycle of regulatory documents, including protocol amendments, Investigator Brochures (IB), and informed consent updates.
• Contributed to scientific dissemination by supporting grant submissions and drafting technical sections of manuscripts for peer-reviewed journals in neonatal environmental health.

Therapeutic Areas: Allergy Immunology, Rare Disease - Adult/ Pediatric

Clinical Trial Oversight & Site Monitoring (CRA-Focused)

• Directed site operations for pivotal Phase III and IV global clinical trials, including high-profile biologic portfolios for Regeneron (Dupixent/dupilumab) and Allakos, ensuring 100% adherence to FDA, ICH-GCP, and IRB regulations.
• Orchestrated Site Initiation (SIV), Interim Monitoring (IMV), and Close-out Visits (COV); served as the primary liaison for sponsor-appointed monitors to verify source data (SDV) and maintain Trial Master File (TMF) integrity.
• Executed "Mock Audits" and internal quality control checks of Investigator Site Files (ISF) and regulatory binders, resulting in zero major findings during sponsor and institutional audits.
• Managed a high-volume caseload of adult and pediatric participants, performing complex clinical assessments, informed consent, and eligibility screening for rare disease and allergy studies.

Translational Science & Laboratory Leadership

• Spearheaded the "Bench-to-Bedside" arm of a neonatal phthalate metabolism study, bridging the gap between clinical outcomes in human neonates and molecular findings in animal models.
• Managed the end-to-end biospecimen lifecycle, overseeing the collection, RNAlater processing, flash-freezing, and IATA-compliant shipment of sensitive blood and tissue biopsies.
• Performed high-precision molecular assays to identify biomarkers of exposure and oxidative stress, including qPCR, Western blotting, ELISA, and MDA assays.
• Supervised and trained research personnel on specialized specimen handling, chain-of-custody documentation, and laboratory safety protocols to ensure data validity.

Regulatory & Data Management

• Directed Investigational Product (IP) accountability, managing the secure storage, temperature monitoring, and dispensation of biologics according to FDA 21 CFR Part 11 and sponsor requirements.
• Led translational data coordination, integrating clinical variables with biological assay results to support exposure-outcome modeling and metabolic profiling.
• Authored and managed complex regulatory submissions, including new protocol applications, IRB/GCO amendments, continuing reviews, and Serious Adverse Event (SAE) reporting.
• Facilitated scientific dissemination by preparing grant applications and drafting technical sections for peer-reviewed manuscripts in neonatal environmental health.

• Participant recruitment and scheduling of subjects for active neoplasm studies: ranging from Glioblastoma to Adenocarcinoma.
• Obtained consent from subjects for studies conducted in the operating rooms and endoscopy suite for tissue resection and biopsy collections.
• Executed study procedures and processed data following good clinical practices, ensuring accuracy in data collection.
• Managed collection, processing, and shipping of biological specimens for analysis, adhering to protocol and training requirements.
• Oversaw maintenance of subject binders and regulatory documents, including delegation logs and FDA forms, to ensure compliance and organization.
• Reviewed charts from the EMR and performed data entry into study Case Report Form (CRF) systems and study databases (redcap, oracle).
• Performs quality checks of source documentation to resolve queries stemming from inappropriately reported and or recorded specimen data and report identified deviations.
• Participate in the feasibility and complexity assessment process for new protocols.
• Assisted in the review and development of standard operating procedures under the guidance of the Principal Investigator.

• Assisted medical oncologists, surgeons, and nurse case managers in Phase 3, investigational new drug (IND), industry-sponsored clinical trial for head and neck carcinoma.
• Recruited, screened, and consented subjects for interventional research studies under the supervision of the Principal Investigator.
• Entered study visit data into Redcap with a focus on accuracy and efficiency to support research integrity.
• Administered questionnaires to subjects, gathering essential data for research analysis.