Saiteja Bandi

About Saiteja Bandi

I am a experienced and dedicated Clinical Research Coordinator with a strong foundation in managing clinical trials, regulatory compliance, and patient engagement. With hands-on experience coordinating multi-center studies across diverse therapeutic areas, I specialize in participant recruitment, informed consent processes, and data integrity. My expertise in FDA regulations, ICH-GCP guidelines, and IRB submissions ensures strict adherence to protocols while maintaining ethical standards. Proficient in electronic data capture systems such as REDCap, Vaidhyo and ClinicalHawk, I excel in maintaining accurate documentation, managing protocol deviations, and ensuring audit readiness. I have successfully collaborated with cross-functional teams, sponsors, and Principal Investigators to deliver high-quality outcomes and advance clinical research initiatives. I hold a Master’s degree in Biomedical and Health Informatics from the State University of New York at Oswego, where I honed my skills in data analysis and healthcare technology. My technical proficiency includes advanced Microsoft Excel, and CTMS, making me adept at streamlining processes and improving operational efficiency. Passionate about innovation in clinical research, I bring a detail-oriented approach, strong organizational skills, and a commitment to advancing patient-centered care through rigorous and ethical clinical trials. I am eager to contribute my expertise and dedication to impactful clinical research projects.

Experience

1. Clinical Research Coordinator

   Ny Scientific Corp

   Mar 2025 — Present

   Managed end-to-end trial activities, including patient screening, randomization, education, and protocol compliance across various therapeutic areas such as gastroenterology, rheumatology, and radiology.*Coordinated SSV, SIV, IMV, and close-out visits, improving compliance and reducing follow-up items.*Maintained ALCOA-C compliant data in RealTime CTMS and eClinicalWorks; updated logs and records.*Facilitated communication with investigators, sponsors, and IRBs to ensure regulatory compliance.*Collected vitals, performed EKGs, managed biosamples, temp logs, and prepared lab kits per protocol.*Handled site supplies, IP, inventory, scheduling, and follow-up calls phone visits with participants.*Resolved data queries and reported Serious Adverse Events (SAEs) and Adverse Events (AEs) in accordance with regulatory requirements.

Education

• Vishnu Dental College, Bheemavaram

  Bachelor of Science, Dental Surgery

• State University of New York at Oswego

  Master of Science, Biomedical and Health Informatics