Bala Sai Sandeep Ullanki
Halifax,Canada
Summary
Healthcare management student with hands-on experience as a patient observer and clinical research associate. Seeking opportunities to apply my skills and knowledge for compassionate patient care and contribute to healthcare excellence.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Patient Observer
Carecor Health Services
05.2023 - Current
- Maintain constant visual observation of assigned patients. Carefully watch the patient's behavior, movements, and activities to ensure their safety and prevent harm or injury
- Communicate any changes in the patient’s condition, concerns, or requests to the staff Nurse to ensure timely and appropriate care
- Assist patients with activities of daily living (ADLs) as needed, such as feeding. Help with repositioning and comfort measures to prevent discomfort or pressure ulcers.
Clinical Research Associate
ICON Clinical Research, IQVIA, Novo Nordisk, Syngene International
09.2016 - 11.2022
- Managed all phases of clinical trials, from initiation to close-out, ensuring compliance with protocol, regulatory requirements, and standard operating procedures (SOPs)
- Conducted site initiation visits, monitoring visits, and close-out visits to ensure the integrity and quality of clinical trial data
- Performed source data review, source data verification, reviewed case report forms (CRFs), and resolved data queries promptly
- Ensured the safety and rights of patients in a clinical trial
- Ensured reporting of adverse events/SAEs/MESIs from clinical trials as per SOPs and regulatory requirements (ICH-GCP, USFDA)
- Accounted for supporting the development of project patient recruitment plan on a per-research hospital basis
- Reviewed master drug accountability log and patient drug accountability logs, Performed subject-specific drug accountability and reconciliation
- Managed supply of Investigational New Drugs as per patient enrolment to all research hospitals
- Prescriptions, lab reports, discharge summaries, Informed consent documents, diagnostic reports, patient diaries, and questionnaires
- Assisted in the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications and Ethics Committee/Institutional Review Board (IRB) submissions.
Education
Post Baccalaureate Diploma - Healthcare Management
Cape Breton University
Nova Scotia, Canada12.2024
PG Certificate - Clinical Research
CRA School
Montreal, QC06.2024
Master’s in pharmacy (MS Pharm.) - Regulatory Toxicology
National Institute of Pharmaceutical Education And Research
Punjab, India05.2016
Skills
- Verbal and written communication skills, Team Work
- Attention to detail, Relationship management, Time management, Stress management
- Medical Terminology, Multi-tasking, Problem-solving, Information analysis
- Microsoft Word, Microsoft Excel, PowerPoint, Outlook, EDC (InFORM, RAVE), Veeva Vault, CTMS, EMR (Epic CareLink, PenMed)
Certification
- Certified Clinical Research Associate (CCRA, ACRP Oct 2020 – Nov 2022)
- Good Clinical Practice (GCP), TCPS 2, CPR & First Aid, Food Safety, WHMIS
Timeline
Patient Observer
Carecor Health Services
05.2023 - Current
Clinical Research Associate
ICON Clinical Research, IQVIA, Novo Nordisk, Syngene International
09.2016 - 11.2022
Post Baccalaureate Diploma - Healthcare Management
Cape Breton University
PG Certificate - Clinical Research
CRA School
Master’s in pharmacy (MS Pharm.) - Regulatory Toxicology
National Institute of Pharmaceutical Education And Research
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