Vijaya Akula
Grand Junction
Summary
Dedicated Clinical Research Coordinator with over 4 years of experience managing Oncology, Urology, and Phase I-III clinical trials. Proficient in regulatory compliance, quality assurance, and patient recruitment, ensuring adherence to industry standards. Expertise in EDC systems and data analysis to improve clinical operations and data integrity. Strong organizational and communication skills enhance collaboration and efficiency in clinical research environments.
Overview
7
7
years of professional experience
6
6
Certifications
Work History
Clinical Research Coordinator
Community Hospital Grand Junction Colorado
07.2025 - Current
- Currently coordinating hospital-based oncology clinical trials across active treatment and follow-up phases.
- Manage screening, informed consent, visit coordination, data entry, and long-term patient follow-up for oncology protocols.
- Support interventional and observational oncology studies, ensuring strict protocol adherence and patient safety monitoring.
- Actively involved in new study start-up, including feasibility coordination, regulatory submissions, site activation, and investigator meetings.
- Perform ongoing regulatory updates, including IRB/IEC submissions, amendments, continuing reviews, safety reports, and deviation reporting.
- Maintain essential regulatory documents and study binders, including delegation logs, training records, and version-controlled consent forms.
- Coordinate oncology patient procedures such as chemotherapy scheduling, labs, imaging, and AE/SAE follow-up per protocol.
- Track and retain participants in follow-up oncology trials, scheduling surveillance visits and maintaining detailed follow-up logs.
- Collaborate with oncologists, research nurses, pharmacists, and data managers to ensure smooth trial conduct.
- Ensure full compliance with ICH-GCP, institutional SOPs, and sponsor requirements across all oncology research activities.
- Maintained accurate records of study protocols and regulatory documentation.
Clinical Research Assistant
Urology of Virginia
Norfolk
01.2024 - 06.2025
- Coordinated data collection and management for research projects, ensuring FDA compliance.
- Facilitated patient recruitment through outreach at local clinics and physician offices.
- Monitored long-term outcomes of transurethral resection of the prostate for benign prostatic hyperplasia.
- Monitored compliance with Good Clinical Practices, International Council on Harmonization guidelines, and applicable regulations.
- Demonstrated efficacy and safety of TURP, shaping best practices in BPH management.
- Administered medications under physician supervision, following established protocols.
- Developed tracking systems for regulatory submissions, including IRB applications and IND Safety Reports.
- Collaborated with clinical teams to ensure protocol adherence and enhance safety measures.
- Prepared documentation for regulatory compliance and ethics review boards.
- Monitored compliance with FDA guidelines.
Clinical Research Coordinator
Manipal Hospitals
Vijayawada
01.2019 - 03.2022
- Demonstrated regulatory compliance expertise, adhering to GCP guidelines and Indian drug regulations while managing end-to-end trial activities.
- Coordinated daily operations across various therapeutic area trials, ensuring protocol guidelines and patient safety.
- Enhanced patient recruitment criteria in high-volume units, achieving 35% enrollment increase through proactive screening and visit coordination.
- Created and reviewed CRFs and source documentation for completeness, accuracy, and consistency across multiple protocols.
- Managed over 100 laboratory sample shipments, ensuring full compliance with IATA regulations and study-specific protocols.
- Developed study-specific source documents and standard operating procedures, reducing clinical workflow setup time by 20%.
- Oversaw documentation and submission of Adverse Events, supporting final safety evaluations and regulatory filings.
- Coordinated Phase II/III clinical trials in NASH and cirrhosis, overseeing screening, informed consent, visit scheduling, and safety follow-up.
Education
Master of Science - Healthcare Informatics
Sacred Heart University
Fairfield, CT, USA12.2023
Bachelor of Science - Pharm. D (Doctorate)
Siddartha Pharmaceutical University
INDIA 05.2022
Skills
- Data monitoring and quality assurance
- Oncology trial coordination
- Research documentation management
- Electronic data capture
- Regulatory compliance
- Risk management
- Deviation detection
- SOP compliance
- CTMS and EDC systems
- Regulatory updates
- Oncology clinical research
- Clinical software proficiency
- Statistical analysis tools
- Informed consent procedures
- Specimen handling
- Project management
- Good clinical practice
Projects
Key Projects
- Barcode Administration Technology Study
Evaluated ADEs and nurse satisfaction in a randomized controlled trial over 6 months at Sacred Heart University. - Oxybutynin Efficacy Trial
Double-blind, placebo-controlled study assessing treatment outcomes in women with urge incontinence (Urology of Virginia) - Perception of Generic vs Brand medications - Observational Randomized study.(Capstone project | 2020-2021)
Core Competencies
Core Competencies
- Clinical Trial Coordination (Phase II & III)
- Data accuracy and integrity.
- Electronic Data Capture
- EMR Systems (Epic, Athena, eClinicalWorks)
- Regulatory Compliance (ICH-GCP, HIPAA, FDA ,GMP standards).
- Risk Assessment and Mitigation.
- Process Improvement and Standardization.
- Adverse Event Reporting
- Clinical Trial Documentation (CRFs, ICFs, Safety Reports)
- Phlebotomy & Medication Administration
Certification
ACRP - Association of Clinical Research Professionals
Timeline
Clinical Research Coordinator
Community Hospital Grand Junction Colorado
07.2025 - Current
Clinical Research Assistant
Urology of Virginia
01.2024 - 06.2025
Clinical Research Coordinator
Manipal Hospitals
01.2019 - 03.2022
Master of Science - Healthcare Informatics
Sacred Heart University
Bachelor of Science - Pharm. D (Doctorate)
Siddartha Pharmaceutical University