Clinical Research Quality Assurance

Hari Chandana Dasari

Boston, MA 857-***-**** ad7i8b@r.postjobfree.com LinkedIn

PROFESSIONAL SUMMARY

Regulatory Affairs enthusiast with familiarity in FDA and EU submissions, quality assurance, and compliance protocols. Skilled in navigating regulatory processes and standards, including ICH guidelines and 21 CFR parts. Proficient in managing regulatory projects, collaborating with stakeholders, and ensuring adherence to industry standards. Excited to contribute expertise in a dynamic regulatory environment, with a proven track record of success in academic and project settings. EDUCATION

Northeastern University, Boston, MA Expected date: June 2024 Master of Science in Regulatory Affairs GPA 3.9/4.0 Coursework: US FDA and EU Regulatory Requirements, Medical Device Development, Quality System Regulations, Regulatory Submissions, Therapeutic Product Development and Regulatory Strategies, Benefit-risk framework, Non-Clinical Regulations in Biomedical Product Commercialization, Strategic Planning and Project Management. Anurag Group of Institutions, Ghatkesar, India August 2021 Pharm-D (Doctor of Pharmacy) GPA 3.7/4.0

Coursework: Pharmacotherapeutics, Pharmacology, Pharmaceutical Analysis, Medicinal Chemistry, Microbiology, Clinical Research, Pharmacoepidemiology.

PROFESSIONAL EXPERIENCE

Basant Sahney Hospital (Hyderabad, India) September 2021 – July 2022 Clinical Research Co-ordinator

• Led and supervised a team of four members in successfully coordinating the collection of essential clinical trial documents, including CDA and Feasibility questionnaires, resulting in the selection and qualification of sites for two trials.

• Worked on 3-4 projects involving an inflammatory drug for Ulcerative Colitis, Crohn’s Disease, and an ointment for anal fissures (Phase 2 and 3 trials), achieving a 90% patient enrollment rate and 98% data accuracy.

• Ensured adherence to regulatory compliance by efficiently supporting the preparation of critical documents such as CTA, CTRI, Insurance, ICF, and Protocol, maintaining a 100% compliance rate and zero regulatory issues.

• Implemented effective recruitment strategies, optimizing the process and achieving an 85% enrollment rate of qualified participants within the specified timeline for the clinical trial.

• Demonstrated proficiency in drug accountability and data management by accurately recording and entering subject visit data into the IWRS system, ensuring protocol-specific activities were followed by SOPs and GCP Yashoda Hospital (Hyderabad, India) July 2020-August 2021 Intern

• Rotated through General Medicine, Pediatrics, Obstetrics, and Gynecology departments and assisted in patient care, conducted patient interviews, and performed physical examinations.

• Gained hands-on experience in diagnosing and treating a wide range of medical conditions and collaborated with healthcare professionals to develop treatment plans and manage patient care.

• Collected medication history, monitored adverse drug reports, and provided patient counseling, addressing around 200 cases. Tulasi Hospital (Hyderabad, India) November 2020-January 2021 Intern

• Completed an internship in patient care within the Emergency Department, demonstrating quick decision-making and effective communication skills in high-pressure situations.

• Gained hands-on experience in the Medical Intensive Care Unit (MICU), providing comprehensive care to critically ill patients and collaborating with a multidisciplinary healthcare team to ensure optimal patient outcomes. Yashoda Hospital (Hyderabad, India) Feb 2020-April 2020 Clinical Research Intern

• Contributed to the successful execution of phase 2 clinical trials by assisting in protocol design, patient recruitment, data collection, and analysis, while ensuring adherence to regulatory guidelines and high data integrity.

• Collaborated with cross-functional teams to prepare and submit essential trial documentation, supporting the smooth progression of clinical research projects.

Nelima Hospital (Hyderabad, India) July 2019-January 2020 Clinical Research Intern

• Contributed to a prospective and retrospective observational study on pregnancy outcomes in women and neonates, focusing on anemia and gestational hypertension.

• Assisted in protocol development, patient enrollment, data collection, and analysis. Gained experience in assessing pregnancy- related complications and their impacts on maternal and fetal health. Obtained 90% accuracy in outcomes using SAS Software and Microsoft Excel.

SKILLS

• Proficient in FDA and EU regulatory processes (IND, NDA, 510k, PMA, IDE, HDE), guidelines (ICH, cGMP, GCP, GLP), document formats (CTD, eCTD), quality assurance (QSR), and therapeutic product profiles. Familiar with food regulations

(USA and EU) and key sections of 21 CFR (50, 820, 807, 814), ensuring regulatory compliance across diverse environments.

• Proficient in MS Office, PowerPoint, Outlook, Microsoft Teams, Office Suite, and MS Excel, WordPress, Share Point. ACADEMIC PROJECT WORK

• XN Project- Collaborated with sponsor Amarastesia to gather information on their CerA&Mvix device, addressing queries on predicate device, device classification, design history file, and 510(k) roadmap.

• Developed a De Novo submission for a medical device using the FDA regulations in a class project.

• Led a team of six in developing and executing regulatory strategies for a Class 2 medical device across six countries. Successfully navigated diverse global regulatory processes, ensuring compliance. Simultaneously crafted and executed a business and budget plan to align regulatory efforts with organizational objectives using Excel.

• Collaborated on filing a Class II medical device, including a special 510k and LFT submission, from the 510k database, content, and format of special 510k ensuring compliance with FDA regulations.

• Researched differences in ICH S9 & M3 guidelines, developed non-clinical data plans for oncology and non-oncology drugs, and identified GLP violations in 5 FDA warning letters. CERTIFICATIONS

• Six Sigma Foundations and Black Belt Certification, Excel tips- LinkedIn Learning. Anti-Microbial Stewardship - Open WHO, Anti-Microbial Stewardship – Pharmacon Society for Pharmacy Practice Organization, Good Clinical Practice - NDA Good Clinical Trial Network, ADR Monitoring - Upsala Monitoring Center. ACTIVITES&INTERESTS

• Student Member of Regulatory affairs Professional Society- participating in workshops and networking events.

• Member of Regulatory Affairs Student Organization- Actively participated in regulatory affairs research and analysis projects to stay updated with industry trends and compliance requirements.

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