Surekha Pusapati
Scarborough,Canada
Summary
Driven Clinical Research Associate with a proven track record at Narayana Super Specialty Hospital, adept in managing clinical trials and ensuring compliance with GCP. Showcases excellent organizational skills and a strong proficiency in REDCap and MS Office Suite. Demonstrates a commitment to quality and efficiency, with a focus on improving patient safety and data integrity.
Overview
5
5
years of professional experience
Work History
QUALITY ASUURANCE ASSISTANT
Gentell.inc
Toronto, Canada
01.2023 - 09.2024
- Update and maintain metric data related to product holds, supporting informed decision-making
- Assist with product holds and disposition from initiation to closure, ensuring timely resolution
- Involved in technical writing/implementing changes to the controlled documents (eg: SOP, Specifications, Methods, Protocols and reports etc) as needed to ensure quality objectives are met
- Performed GMP periodic document revision using document change request (DCR) process in manual system and EDMS systems
- Supported in development and structure of processes batch records include for issuing, tracking and reviewing batch records
- Demonstrate through knowledge of applicable procedures, regulations, and standards
- Offer technical guidance and training to staff on SOPs and quality guidelines
- Review of the finished batch manufacturing record
- Coordinate within manufacturing facility from QA, QC, Engineering to manufacturing departments regarding any issues based on cGMP
- Create labels for Raw Material & Finished Products
CLINICAL RESEARCH ASSOCIATE / CLINICAL PHARMACIST
Narayana Super specialty Hospital
Guntur, India
08.2020 - 08.2021
- Worked under 6 – 8 Physician in different departments like Orthopedics, Cardiology, Gastroenterology, Family Medicine, Pediatrics
- Managed trial-related documents, including technical regulatory document review, informed consent forms, and protocol-related documents, ensuring completeness and accuracy
- Coordinated and tracked study data, investigational products, and financial disclosures, ensuring compliance with internal SOPs and client policies
- Ensured audit and inspection readiness by maintaining up-to-date documentation and addressing any process improvements
- Conducted site feasibility assessments and provided administrative support during site management evaluations
- Managed logistic and administrative tasks for clinical trials feasibility, start-up, execution, and close-outs
- Maintained patients records and regulatory files, monitored patients’ safety and adverse events and maintained protocol and FDA compliance
- Maintained comprehensive study binders (both electronic and paper) for multiple studies, ensuring timely updates of regulatory documents
- Ensured quality of data through Source Data Verification, Source Data Review in conjugation with centralized monitoring in a Risk Based quality Management
- Data entry from Source document into eCFR including re-entry and data cleaning
- Conducted Literature review and gathered information from different sources required for clinical trails
- Supported the Project Manager in study operations managing regulatory requirements, including obtaining signatures, collecting CVs, medical licenses, and training documentation
- Reported adverse events and documented
- Updated data through electronic platform like REDcap
CLINCAL PHARMACIST INTERN
Aster Ramesh Hospitals
Guntur, India
06.2019 - 08.2020
- Conducted regular ward rounds and treatment chart review alongside other health professionals
- Applied clinical knowledge in prescription auditing and medication counseling in a tertiary care hospital setting
- Worked across departments in patient care rounds in assessing drug interactions, medication errors, and adverse events
- Liaised with physicians on the drug utilization evaluation and acted as a coordinator for the same
- Prepared study documents (CRF’s) according to IEC regulations
- Reviewed and submitted study documents (Protocol and ICF) for IRB approvals
- Collaborated with different departments involved in study to ensure appropriate initiation and maintenance of study
- THESIS: Assessment of Drug Compliance in Acute Ischemic Stroke Patient- A prospective Observational Study in a tertiary care hospital
Education
Post-Degree Diploma - Clinical Trail Management
University of Western Ontario
London, ON08.2025
Masters - Medical Biotechnology
University of Windsor
Windsor, ON12.2022
Doctor Of Pharmacy -
Vignan Pharmacy College
Guntur, India11.2020
Skills
- Excellent organizational skills and time management skills, with the ability to handle multiple priorities in a matrix environment
- Knowledge of Good Clinical Practice (GCP), Health Care Compliance (HCC), and local regulatory requirements
- Strong interpersonal skills, the ability to collaborate, and good negotiation skills
- Self-disciplined, with a proactive approach to work, and a willingness to learn
- Proficient in English, literature review, and has previous experience in publishing articles
- Budget management and vendor management
- Trail Management System (VeevaVault TMF), PV Reporting (ARGUS Safety)
- Strong proficiency in the MS Office Suite (Word, Excel, PowerPoint, Outlook, Access)
- Technical Skills: REDCap, MedDRA Dictionary, SPSS version 220, MS Office software (Word, PowerPoint, Excel, Project)
Publications
Nakka, Varshitha, Pusapati, Surekha, Manukonda, Ajay, Kumarvelu, S., Prasad, Assessment Of Drug Compliance And Targeted Pharmacist Intervention In Acute Ischemic Stroke Patient, International Journal of Pharmacy Practice, 10.31838/International Journal of Pharmacy Practice/2021.13.01.398
References
Available upon request
Knowledge And Certifications
- Tri-council Policy Statement: Ethical Conduct for Research Involving Humans course on Research Ethics (TCPS2: CORE)
- Regulations of Medical devices in Canada – Health Canada
- Handling and Transportation of Dangerous goods- Mayo Clinic
- ICH- GCP by CITI Canada
- Health Insurance Portability and Accountability Act (HIPAA)
Research
Assessment of Drug Compliance in Acute Ischemic Stroke Patient- A prospective Observational Study in a tertiary care hospital
Timeline
QUALITY ASUURANCE ASSISTANT
Gentell.inc
01.2023 - 09.2024
CLINICAL RESEARCH ASSOCIATE / CLINICAL PHARMACIST
Narayana Super specialty Hospital
08.2020 - 08.2021
CLINCAL PHARMACIST INTERN
Aster Ramesh Hospitals
06.2019 - 08.2020
Post-Degree Diploma - Clinical Trail Management
University of Western Ontario
Masters - Medical Biotechnology
University of Windsor
Doctor Of Pharmacy -
Vignan Pharmacy College
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