Somia Sadruddin

About Somia Sadruddin

Clinical Project Manager & Research Leader with 8 years of healthcare experience…

Experience

1. Clinical Research Coordinator

   HubSpot

   Feb 2024 — Present · Dallas, TX, US

   Managed all aspects of clinical trials while ensuring protocol compliance and adherence to Good Clinical Practice (GCP) standards. Successfully conducted subject recruitment, screening, and enrollment, maintained regulatory documentation, and facilitated study visits in alignment with protocol requirements. Collaborated effectively with sponsors, vendors, regulatory authorities, and multidisciplinary teams to ensure seamless trial execution.Key Responsibilities- Study Management: Coordinated study activities, including obtaining informed consent, preparing regulatory binders, and ensuring adherence to protocol requirements- Regulatory Compliance: Maintained accurate and up-to-date regulatory documentation (e.g, consent forms, 1572s, safety reports) and ensured compliance with federal regulations and IRB guidelines- Data Management: Entered and maintained data in EDC systems, addressed queries promptly, and monitored for protocol deviations and adverse events- Participant Engagement: Educated subjects on study procedures, medications, and potential side effects while ensuring their safety and well-being throughout the study- Specimen and Drug Accountability: Processed, handled, and shipped lab specimens, maintained temperature logs, and managed drug inventory and accountability- Staff Training: Trained and onboarded new team members, ensuring they were equipped with the knowledge and skills to support clinical trials effectively, fostering company growth- Communication and Training: Attended investigator meetings, completed required training, and facilitated effective communication between study stakeholders.

Education

• University of Oklahoma

  Bachelor of Science - BSc