Santhosh Gopu
Summary
Passionate Clinical Research Coordinator with a strong academic foundation and hands-on experience in laboratory techniques and clinical research. Committed to advancing scientific understanding and improving patient outcomes through collaboration and innovative solutions.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Wright State Physicians
08.2024 - 12.2024
- As a certified Clinical Research Coordinator, I oversaw clinical research projects, ensuring adherence to ICH-GCP guidelines and SOPs.
- Utilized CTMS, Redcap, and EDC for data analysis and alignment with trial objectives.
- Managed data collection, entry, and trial documentation in eTMF, ISF, and CDMS.
- Collaborated with clinical teams to ensure accurate documentation in EMRs and source documents.
- Drafted and reviewed ICFs, CRFs, patient guides, and study-specific materials.
- Conducted clinical site monitoring using IRT and managed investigational product inventory.
- Collected blood and urine samples, performed centrifugation, and handled sample shipping to sponsors.
- Participated in site initiation, pre-study, post-study, and interim monitoring visits.
- Addressed protocol deviations and ensured compliance during audits and monitoring visits.
- Provided patient education, phlebotomy services, and supported sample handling per IATA standards.
- Conducted literature reviews and maintained regulatory compliance with IRB and sponsor requirements.
Clinical Research Assistant
Kamineni Institute of Medical Science
07.2022 - 06.2023
- Recruited patients for clinical trials (oncology, dermatology, cardiology, neurology, pediatrics) by adhering to inclusion/exclusion criteria, monitoring vital signs, dispensing dosages, and providing patient counseling.
- Collected ADR reports, supported NDA processing, and ensured adherence to ICH-GCP and regulatory standards.
- Addressed protocol deviations, ensured data accuracy, and maintained compliance.
- Played a key role in protocol design, data collection, and monitoring across Phases I-III, prioritizing data integrity.
- Utilized Clinical Data Management tools and Redcap for data entry and analysis.
- Led site start-up activities, including IRB/EC submissions, tracking, and documentation in ISF and eTMF.
- Specialized in pulmonary and other therapeutic areas, contributing insights during clinical trials.
- Conducted quality audits, regulatory inspections, and comprehensive literature reviews for protocol development.
Assistant Clinical Pharmacologist
Shri Wazra Multi Specialty Hospital
10.2020 - 06.2022
- Manage ADR reporting, dose monitoring, blood drawing, phlebotomy and calculations based on age and conditions. Provide patient counseling, first aid, and support in emergencies.
- Interpret ECG/EKG to assess cardiac drug effects. Optimize medication safety, efficacy, and compliance with PK-PD monitoring.
- Collaborate with teams to enhance outcomes. Support formulary management, cost-effective prescribing, and quality improvement.
- Lead clinical research, educate professionals, and ensure compliance.
Education
Master's - Pharmacology and Toxicology
Wright State University
01.2024
PharmD (Doctor of Pharmacy) - undefined
Samskruthi College of Pharmacy
01.2023
Skills
- Laboratory Skills: Laboratory management, Animal handling (Rodents), Western Blotting, Chromatography, Analysis techniques, cell culturing, GLP, Sample Handling, Analytical Methods, Validation, Sterilizing Techniques, GMP/cGMP, Lab techniques
- Clinical skills: CPR, First Aid, BLS, Clinical Data Management, Literature reviewing, Phlebotomy, Case studies, ADR reporting, NDA processing, Good Clinical Practice (ICH-GCP) and Standard Operating Procedures (SOPs), CTMS, eTMF, ISF, IRT, EMR
- Technical skills: Word, Excel, Outlook, Office365, PowerPoint, Redcap, Minitab
Certification
Good Clinical Practice and ICH (GCP)
IATA, BLS, Health Privacy (HIPAA)
Lean Six Sigma Green Belt
Biomedical Research Investigators, Conflicts of Interest
Clinical Research Coordination
IRB Vulnerable Populations Biomedical
Introduction to Clinical Trials (ACRP)
Initial Biosafety, Animal Biosafety Training
Human gene transfer
Situation Awareness Specialist (SAS)
Responsible Conduct of Research (RCR)
Lab Chemical, Laser, Radiation Safety, Hazard Communication
Improving clinical outcomes by optimization of antibiotic practices
Timeline
Clinical Research Coordinator
Wright State Physicians
08.2024 - 12.2024
Clinical Research Assistant
Kamineni Institute of Medical Science
07.2022 - 06.2023
Assistant Clinical Pharmacologist
Shri Wazra Multi Specialty Hospital
10.2020 - 06.2022
PharmD (Doctor of Pharmacy) - undefined
Samskruthi College of Pharmacy
Master's - Pharmacology and Toxicology
Wright State University
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