Akshitha Reddy Kasireddy
Dallas,USA
Summary
MPH graduate with extensive knowledge in public health studies and hands-on experience in laboratory and research environments. Proven expertise in clinical research coordination, including managing clinical trials, ensuring compliance with HIPAA, FDA regulations, and Institutional Review Board requirements. Demonstrates strong organizational skills and the ability to efficiently manage multiple tasks while maintaining accuracy in documentation and reporting. Notable contributions include enhancing trial procedures and improving data integrity.
Overview
6
6
years of professional experience
Work History
Lead Clinical Research Coordinator II
Tempus AI.
Remote
08.2023 - Current
- Serving as a Lead Clinical Research Coordinator, supporting oncology clinical trials managed internally at Tempus AI.
- Independently managing 8+ active oncology clinical trials (interventional and observational) across multiple solid tumor indications.
- Primary focus on multi-site patient screening, reviewing medical records across multiple institutions to assess eligibility, and match patients to appropriate TIME clinical trials.
- Conducting comprehensive eligibility assessments using protocol criteria, molecular profiling, and clinical data, contributing to improved patient-to-trial matching, and enrollment efficiency.
- Supporting screening and enrollment activities across several sites simultaneously, acting as a centralized resource for trial feasibility, and patient identification.
- Lead rapid study activations for Just-In-Time (JIT) trials, consistently achieving study activation within 2–4 weeks.
- Participating in site capability and feasibility assessments, evaluating site infrastructure, staffing, workflows, and prior trial experience to determine suitability for trial participation.
- Contributing to internal projects and initiatives, including workflow optimization, process improvement, and standardization efforts to enhance trial operations and scalability.
- Providing ongoing education and updates to Principal Investigators, and research staff regarding available TIME trials, protocol changes, and enrollment status.
- Performing remote data management and quality oversight, including EDC entry, source review, and query resolution in EPIC, RAVE, REDCap, and Medrio.
- Supporting monitoring visits, audits, SIVs, and COVs, with minimal to no major findings.
- Maintaining complete and audit-ready regulatory documentation in compliance with GCP, and protocol requirements.
- Participating in molecular tumor boards and physician meetings to support real-time patient review and trial matching.
Clinical Research Coordinator
Tempus AI | TriHealth – Good Samaritan Hospital
Cincinnati, OH
08.2023 - 03.2025
- Conducted oncology clinical trials on-site as a TIME CRC supporting Tempus AI at TriHealth – Good Samaritan Hospital.
- Managed 8+ oncology trials across Phases I–IV, including thoracic, gynecologic, breast, and urothelial cancers, with a strong focus on immunotherapy and chemotherapy protocols.
- Recruited, screened, consented, and enrolled over 40 patients across multiple studies, consistently meeting or exceeding enrollment targets.
- Performed detailed eligibility assessments, contributing to low screen failure rates, and protocol adherence.
- Coordinated 100+ study visits, including participant scheduling, dosing, observation, AE monitoring, and safety reporting.
- Performed clinical procedures, including phlebotomy, ECGs, specimen collection, processing, and shipment, in compliance with protocol and lab requirements.
- Managed investigational product and equipment inventory with zero drug accountability discrepancies.
- Managed clinical data entry and query resolution across EPIC, RAVE, REDCap, and Medrio, consistently closing queries within 24–72 hours, and supporting on-time database updates.
- Supported monitoring visits, audits, SIVs, and COVs, ensuring inspection readiness and timely follow-up on action items.
- Maintained regulatory binders and source documentation with no major findings during sponsor and CRO reviews.
- Communicated effectively with sponsors, CROs, monitors, investigators, and hospital staff to ensure smooth trial operations.
Clinical Data Analyst
Cincinnati College of Medicine
Cincinnati, USA
08.2022 - 04.2023
- Worked on NIS data (Nationwide Inpatient Sample) 2019 by creating subsets of the data related to renal failure to estimate the incidence of dialysis among the sufferers of chronic kidney disease.
- Analyzed and interpreted data from various studies including clinical trials, observational studies, and public health surveys.
- Reported the demographics of the data and performed a logistic regression model using SAS for a more comprehensive study of the data.
- Presented odds ratios to assess the strengths of risk factors.
- Developed written and oral presentations to communicate complicated statistical concepts and results to medical and public health researchers and practitioners, community partners, and policymakers effectively.
- Applied principles of good ethical practice related to study design, data collection, and dissemination. Performed the literature review.
- Division of Biostatistics, Department of Environmental and Public Health Sciences
Clinical Research Coordinator
KIMS
, India
08.2019 - 09.2020
- Participated in research initiatives, overseeing subject recruiting, study protocol execution, data collecting and processing, and coordination of a particular study or group of studies.
- Maintained current and accurate records.
- Complied with protocol and training requirements while gathering, labeling, logging, processing, and shipping biological specimens for analysis.
- Obtaining detailed knowledge of all components of study protocol through independent analysis and review of study to complete all study activities correctly and completely.
- Reviewing with all members of the research team all study procedures prior to initiation date to ensure an understanding and acceptance of roles and responsibilities for proper performance during the study.
- Scheduled for subjects to undergo protocol-related tests; worked with doctors, researchers, and other healthcare professionals.
- Ensuring regulatory compliance. Regularly inspecting study documents to ensure ongoing regulatory compliance.
- Evaluated data from hospitals, physicians, and other sources of disease clusters and helped to identify previously unrecognized illnesses.
- Involved in submissions related to clinical trials.
- Systematic reviews of literature, journals, and abstracts were conducted.
Education
Master of Public Health (MPH) -
University of Cincinnati
Cincinnati, Ohio, USA04.2023
Doctor of Pharmacy (PharmD) -
Jawaharlal Nehru Technological University
Hyderabad, India10.2020
Skills
- R
- SAS
- Microsoft Excel
- MEDIDATA RAVE
- REDCap
- MEDRIO
- EPIC
- Regulatory compliance
- Patient recruitment
- Electronic data capture
- IRB submissions
- GCP training
- Data collection
- Study closeout
- Site monitoring
- Phlebotomy
- Good clinical practice
- Adverse event tracking
- Effective communication
- Team collaboration
Publications
Liver Injury in Covid-19: Etiology, Treatment, Prognosis, and Challenges, Kasireddy Akshitha Reddy, et. al., IOSR Journal of Dental and Medical Sciences (IOSR-JDMS), 19, 9, 2020, 38-44, https://www.researchgate.net/publication/344241574_Liver_Injury_in_Covid19_Etiology_Treatment_Prognosis_and_Challenges
Graduate Research Projects
- Effects of Trestbps on cholesterol and FBS levels, Statistical and inferential analysis was done using ANOVA.
- Epidemiology - Race and Socio-economic Status: The Impact on Type 2 Diabetes in Children of Cincinnati, A randomized clinical trial involving both experimental manipulation and randomization.
- Impact of Intravenous Proton Pump Inhibitors (PPI) in Prevention and Management of Upper Gastrointestinal Bleeding, Investigated how the history of prior treatments affects remission.
Leadership Experience
- Public Health Navigator, UC Public Health Response Team, 05/22, 05/23, Worked as a contact tracer for COVID-19 patients.
- Radiology Reading Room Representative, UC Health, 11/21, 02/23
Timeline
Lead Clinical Research Coordinator II
Tempus AI.
08.2023 - Current
Clinical Research Coordinator
Tempus AI | TriHealth – Good Samaritan Hospital
08.2023 - 03.2025
Clinical Data Analyst
Cincinnati College of Medicine
08.2022 - 04.2023
Clinical Research Coordinator
KIMS
08.2019 - 09.2020
Master of Public Health (MPH) -
University of Cincinnati
Doctor of Pharmacy (PharmD) -
Jawaharlal Nehru Technological University