Jyothi Reddy

Clinical Research Coordinator @Novotech

Boulder, CO, US

Ensured strict adherence to GCP guidelines and regulatory requirements throughout all stages of clinical trials, ensuring smooth operations.• Addressed protocol deviations and data discrepancies promptly, ensuring both data accuracy and compliance with regulations.• Enhanced recruitment strategies, increased patient enrollment by 25%, and contributed to timely trial completion.• Managed key study documentation, including eTMFs and case report forms, ensuring accuracy and easy access.• Collaborated with lead physicians in specialties like cardiology, neurology, oncology, and pediatrics to align research goals and maintain effective communication.• Contributed to protocol development and played a significant role in data collection and monitoring, ensuring study compliance and data integrity.• Gained comprehensive experience across clinical trial phases (I, II, from recruitment to data analysis.• Assisted with IRB/EC application submissions, ensuring timely approvals and streamlined approval processes.• Collaborated with cross-functional teams, ensuring the effective execution of trial protocols and the achievement of study objectives.• Screened and selected participants based on eligibility criteria, ensuring correct participant selection.• Provided pharmaceutical expertise to healthcare providers and participants, ensuring proper drug administration and safety monitoring.• Prepared and submitted regulatory documents, including ethics committee applications and informed consent forms, ensuring compliance and accuracy.• Analyzed and organized study data, using statistical methods to provide key insights for investigators and sponsors.• Contributed to team meetings, offering updates and actively participating in discussions to address challenges.• Led discussions to resolve trial issues, adapting protocols as needed to maintain trial progress and integrity.

Siddhartha Institute of Pharmacy

Bachelor's degree

Sacred Heart University

Healthcare Informatics