Maalika Ch

Clinical Research Associate

Novum Pharmaceutical Research • Temps plein

Jan 2025 - Dec 2025 • 11 mos

• Executed site identification, initiation, monitoring, remote data review, and closeout activities for 15+ biotechnology-sponsored clinical trial sites in alignment with Clinical Monitoring Plans (CMPs), ensuring 100% adherence to ICH-GCP, FDA, and biotechnology-specific regulatory standards. • Trained and supported 30+ investigators and site staff on biologic drug protocol, Risk-Based Quality Management practices, and patient safety processes, driving a 20% improvement in protocol compliance, accurate biologics data documentation, and data integrity across all study phases. • Designed and rolled out site recruitment and enrollment strategies, enabling 95% achievement of accural milestones within projected timelines while tracking screening rates, retention, subject onboarding metrics, optimizing trial efficiency for novel biologics and biosimilars. • Prepared and finalized 40+ Monitoring Visit Reporting CTMS, tracked quality indicators (SDV, query resolution, action item closure, MV timelines), and managed 10+ IRB/EC submissions and eTMF QC checks, ensuring audit readiness and compliance for biotech-based clinical programs.

Clinical Research Associate

Calyx • Temps plein

Jan 2023 - Dec 2023 • 11 mos

• Managed Electronic Data Capture (EDC) systems including Medidata Rave and InForm, ensuring accurate data entry, validation, and compliance with FDA 21 CFR Part 11, HIPAA, and GCP standards across Oncology, Cardiovascular, Diabetes, and Dermatology studies. • Prepared and delivered audit-ready Monitoring Visit Reports (MVRs), Site Visit Reports (SVRs), and Risk-Based Monitoring (RBM) plans, aligning with ICH-GCP guidelines and sponsor SOPs to strengthen trial compliance. • Developed and implemented Corrective and Preventive Action (CAPA) plans, achieving a 15% reduction in protocol deviations and enhancing site preparedness for regulatory inspections and audits. • Maintained comprehensive regulatory documentation within Clinical Trial Management Systems (CTMS) such as Veeva Vault and Medrio, ensuring ongoing compliance with sponsor requirements and U.S. regulatory standards.

Senior Clinical Research Specialist

Parexel • Temps plein

Dec 2019 - Dec 2021 • 2 yrs

• Managed 20+ clinical trial sites across Oncology, Cardiovascular, Diabetes, and Dermatology studies (Phases I–IV), ensuring protocol compliance, participant safety, and regulatory adherence in alignment with FDA, EMA, and ICH-GCP guidelines. • Conducted 50+ on-site monitoring visits, performing data verification, reviewing source documentation, and ensuring accuracy, integrity, and compliance with ALCOA-C principles across all trial datasets. • Compiled and submitted 15+ regulatory documents (INDs, NDAs, CTAs) with 100% accuracy and on-time delivery, maintaining up-to-date knowledge of global regulatory standards and clinical data governance requirements. • Led oncology imaging quality control and analysis for 15+ trials, processing 500+ imaging datasets (MRI, CT, PET) using proprietary/third-party tools, while resolving 100+ site and subject-level queries to strengthen data quality, integrity, and audit readiness.