SAI PRIYANKA ANNADASU
Tampa,FL
Summary
Clinical Research Coordinator with 5 years of experience supporting all phases (Phase I-IV) of clinical trials across multiple therapeutic areas. Strong background in regulatory compliance, site operations, and monitoring support, with hands-on experience preparing sites for monitoring visits, maintaining audit-ready documentation, resolving data queries, and collaborating closely with CRAs, sponsors, and investigators. Motivated to grow into a CRC, CRA I, or In-House CRA roles.
Clinical Research Coordinator with experience in grants, Writing, drafting publications, designing study protocols, leading investigator meetings, and conducting clinical trials. Graduate student completing a Master of Science with an emphasis on neuroscience/neurosurgery research.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator 2
Tampa General Hospital
Tampa, USA
10.2025 - Current
- Coordinated operations across multiple clinical trials by managing patient enrollment and informed consent (ICF), case report forms (CRFs), ensuring strict compliance with HIPAA, FDA, and GCP standards, resulting in zero protocol violations in monitored audits.
- Extensive experience with Florence eBinder, Velos (CTMS), RedCap Cloud, RedCap, Zelta, Medidata, RDC, Viedoc, Registry EDC systems, and WCG, Advarra IRB.
- Serve as the primary point of contact for study-related questions, supporting site enrollment, study conduct, and protocol compliance.
- Support site initiation, monitoring, and close-out activities by preparing regulatory documentation, resolving data queries, and coordinating with CRAs, and sponsors.
- Maintain complete, accurate, and audit-ready regulatory files (ISF/TMF), ensuring version control, and timely document updates.
- Track and support the management of protocol deviations, adverse events, and corrective actions in collaboration with investigators and sponsors.
- Oversee investigational product and device accountability in accordance with protocol and sponsor requirements.
- Support planning and coordination of investigator meetings, monitoring visits, and study-related trainings.
- Conducted training sessions for clinical staff and new coordinators on informed consent procedures, documentation standards, and regulatory compliance, enhancing team competency, and reducing documentation discrepancies.
Clinical Research Coordinator
Mayo Clinic
MN, USA
07.2023 - 09.2025
- Collaborated with principal investigators, sub-investigators, compliance team members, regulatory analysts, and clinical teams to manage daily trial operations across multiple therapeutic protocols.
- Supported patient coordination and management of Phase I, II, and III oncology clinical trials across multiple therapeutic protocols, ensuring adherence to study protocols, regulatory requirements (FDA, ICH-GP), and institutional guidelines.
- Supported patient recruitment and retention strategies by identifying site-level barriers, enhancing visit adherence, fostering informed participation, and ensuring patient safety.
- Prepared and submitted regulatory documents, including IRB protocols, informed consent forms, and FDA IND/IDE applications, ensuring timely and compliant submissions.
- Entered and validated study data in EDC systems (REDCap, Medidata), performed query resolution, and conducted routine quality control checks, ensuring data integrity and successful audit outcomes.
- Managed investigational product accountability, ensuring accurate receipt, storage, dispensing, and return according to study protocols and regulations.
- Identified, documented, and reported adverse events, protocol deviations, and other unanticipated problems to the IRB and sponsors, initiating and tracking CAPA implementation to closure.
- Collaborated effectively with Principal Investigators, Data Managers, and clinical teams to manage daily trial operations, and ensure seamless patient care in the oncology setting.
- Conducted quality assurance activities, root cause analyses, and implemented workflow improvements with QA and data management teams to enhance trial efficiency and compliance.
- Maintained regulatory documentation, source files, and version-controlled records in compliance with institutional and sponsor requirements, ensuring audit readiness and regulatory compliance.
- Participated in monitoring visits and audits, addressed protocol deviations, and contributed to the development and implementation of CAPA plans.
Clinical Research Coordinator
Johns Hopkins University School of Medicine
MD, USA
01.2023 - 06.2023
- Coordinated and managed multiple Phase I, II, and III cardiology clinical trials, ensuring strict adherence to FDA regulations, ICH-GCP guidelines, and site-specific Standard Operating Procedures (SOPs).
- Successfully recruited, screened, and consented eligible cardiology patients, utilizing established protocols and tools like EPIC EHR for efficient identification, reviewing charts, contributing to target enrollment achievement, and high retention rates.
- Led the preparation and submission of IRB applications and amendments for cardiology studies, securing timely approvals, and maintaining continuous regulatory compliance per SOPs.
- Successfully recruited, screened, and consented eligible participants, consistently exceeding enrollment targets, and achieving an average participant retention rate of 90%.
- Conducted meticulous data collection and documentation using both electronic and paper-based Case Report Forms (CRFs), ensuring data integrity, and timely reporting within systems like Medidata Rave.
- Maintained comprehensive, audit-ready study files and regulatory binders, including source documents and CRFs, facilitating seamless monitoring visits, and ensuring full compliance.
- Fostered strong collaborative relationships with Principal Investigators (PIs), cardiologists, study sponsors, and participants, ensuring efficient study execution, and prioritizing patient safety within the clinical trials.
- Streamlined patient recruitment and scheduling by leveraging the EPIC EHR system to identify potential participants and manage study visit logistics, contributing to increased enrollment efficiency.
- Ensured rigorous adherence to ethical research practices within the cardiology division, consistently safeguarding the rights, welfare, and confidentiality of all study participants by following established SOPs and institutional policies.
- Ensured rigorous adherence to ethical research practices, safeguarding the rights, welfare, and confidentiality of all study participants within the cardiology division, in full compliance with HIPAA regulations and IRB requirements.
Clinical Research Coordinator
Manipal Hospitals
, India
01.2020 - 12.2021
- Conducted patient screening and recruitment by verifying eligibility criteria, obtaining informed consent, and coordinating study visits, which increased trial enrollment efficiency by 10% while maintaining compliance with IRB and GCP standards.
- Prepared and kept the case report forms (CRFs) up to date, and validated clinical data in EDC and CTMS platforms, resolving discrepancies and ensuring accuracy for interim and final analyses, contributing to high-quality and audit-ready datasets.
- Monitored patient visits, adverse events, and protocol adherence, escalating critical deviations to investigators and regulatory teams, improving patient safety reporting, and minimizing risk exposure.
- Prepared investigator site files and essential trial documentation for audits, monitoring visits, and inspections, consistently meeting regulatory standards, and reducing audit findings.
- Mentored junior research coordinators by providing training in recruitment, documentation, and regulatory compliance, improving overall team efficiency and protocol adherence.
Education
Master of Science - Health Informatics
The University of Findlay
Findlay, OH, USABachelor of Science - Pharmacy
KC Reddy Institute of Pharmacy
Guntur, IndiaSkills
- Clinical Research
- Clinical Trials
- Pre-Study Visit
- Site Initiation Visit
- Interim Monitoring Visit
- Close-Out Visit
- First Author of Publication
- Statistical Data Analysis G
- Grant Writing
- Regulatory Compliancе
- Biology
- Leadership Communication
- Problem Solving
- Clinical Monitoring
- Clinical Supervision
- Management
- Research written materials
- Institutional Review Board (IRB) Materials
- Informed Consent Materials
- SPSS
- Conference presentations
- Neuropsychology
- NeuroSurgery/NeuroScience
- Detail Oriented
- Efficient
- Fast Learner
- Ability to work independently
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Access)
- Therapeutic Area Expertise (Neurosurgery, Oncology, Cardiology, Nephrology, Pediatrics, Neurology, Device Trials, Cell Therapy)
Certification
• Florence eBinders- Florence Healthcare
• IATA Certificate - CITI
• Human Subjects Protection (HSP) - Advarra
• Foundations of Clinical Research - TGH/USF Office of Clinical Research • HIPAA Certification -American Health Training
• Good Clinical Practice - CITI
• Good Clinical Practice (GCP) Certification- National Institute of Health (NIH)
• Biomedical Research Certification - CITI
• Social and Behavioral Responsible Conduct of Research - CITI
• NIHSS Certificate - BlueCloud
• mRS - BlueCloud
• CSSRS - BlueCloud
• MoCA - MoCA Cognition
• IATA Certificate - CITI
• Human Subjects Protection (HSP) - Advarra
• Foundations of Clinical Research - TGH/USF Office of Clinical Research • HIPAA Certification -American Health Training
• Good Clinical Practice - CITI
• Good Clinical Practice (GCP) Certification- National Institute of Health (NIH)
• Biomedical Research Certification - CITI
• Social and Behavioral Responsible Conduct of Research - CITI
• NIHSS Certificate - BlueCloud
• mRS - BlueCloud
• CSSRS - BlueCloud
• MoCA - MoCA Cognition
ACADEMIC PROJECTS
- Patient Recruitment and Informed Consent Workflow Optimization Project | Clinical Trial Management System (CTMS)
- Designed structured recruitment and consent workflows using CTMS tools to improve documentation accuracy and enrollment tracking. Built tracking logs for enrollment, visit schedules, and adverse event reporting.
- Proper Regulatory Documentation and Site Monitoring Project
- Performed mock site monitoring activities aligned with GCP and FDA guidelines and ensured proper version control and archival of regulatory binders and CRFs.
Affiliations
- University of Findlay Master’s Merit Scholarship Awardee (Jan 2022)
- University of Findlay GRE/GMAT Scholarship Recipient (Jan 2022)
Timeline
Clinical Research Coordinator 2
Tampa General Hospital
10.2025 - Current
Clinical Research Coordinator
Mayo Clinic
07.2023 - 09.2025
Clinical Research Coordinator
Johns Hopkins University School of Medicine
01.2023 - 06.2023
Clinical Research Coordinator
Manipal Hospitals
01.2020 - 12.2021
Master of Science - Health Informatics
The University of Findlay
Bachelor of Science - Pharmacy
KC Reddy Institute of Pharmacy