Soumya Erri

Dayton, Ohio Tel: 332-***-**** Mail: ad3o05@r.postjobfree.com LinkedIn: soumya-erri-55a8aa266 Professional Summary

Highly motivated and accomplished Clinical Trial Coordination (Pharmacology and Toxicology) student with a strong academic background and registered Pharmacist in India. Hands-on experience from a clinical research Internship in a master’s program. Proven proficiency as a student laboratory assistant with experience in formulating and evaluating various dosage forms. creative thinker with good communication skills and problem- solving capabilities with a team and individual work Research skills

Patient Care/handling, Research Skills, Clinical Trials, CRF, IRB, IND, CTA, CAPA, ICF, SOP, EDC, NDA, Good Clinical Practices (ICH-GCP), Clinical Management, FDA, FDA 1571, 1572, 3674, 3454, 3455, MedWatch, Scientific Writing and proofreading, clinical pharmacy. Laboratory skills: pipetting, chromatography, analysis, Cell culture, and quality control. Education

Wright State University (Boonshoft School of Medicine) (August 2022- December 2023) Dayton, OH

• Master of Pharmacology and Toxicology (GPA: 3.76) Major- Clinical Trial Coordination (CTC)

Related courses: Clinical Research Roles and responsibilities, Cell Biology, pharmacology, Human study research, Laboratory management, effective scientific writing, pharmacology graduate research. Vaagdevi College of Pharmacy (KU) (September 2017- September 2021) Telangana, India

• Bachelor of Pharmacy (GPA: 3.5)

Related courses: pharmacology, microbiology, medicinal chemistry, biochemistry, industrial pharmaceutics, hospital pharmacy, pharmaceutical analysis, regulatory affairs, Quality assurance, organic chemistry. Student Internships: -

Clinical Research Intern at Wright State Physicians Dayton, Ohio, USA

(September 2023- December 2023)

• Collaborated with co-workers, leadership, study subjects, sponsors, CROs, and vendors through email, phone, and in-person meetings.

• Patient scheduling and Scheduled patient tests and interviews and conducted telephone follow-ups to ensure timely study completion.

• Performed front office duties, including answering phones, scheduling appointments, making reminder calls, and updating patient tracking systems.

• Participated in patient recruitment tasks, including prescreening potential subjects via phone or in person.

• Understood and practiced the informed consent process, ensuring initial and ongoing consent of study subjects.

• Assisting in the conduct of clinical trials by the study protocol, GCP, and ICH Guidelines

• Entered source data into sponsor/vendor data portals, resolved basic queries, ensured data accuracy, and Maintained confidentiality of patient-protected health information and sponsored confidential information. Assess the eligibility of research subjects by the approved protocol and all applicable regulations including HIPAA.

• Potential patient safety issues, such as adverse events, were escalated to the Clinical Research Team.

• Cleaned, organized, and disinfected patient care, lab, and lab equipment areas after finishing the patient visit.

• Processed, packaged, and shipped laboratory specimens according to protocol and IATA regulations.

• Tracked, ordered, and maintained inventory of laboratory and study-related supplies throughout the internship.

• Prepared source document charts copied and/or filed medical records and study-related documents.

Student intern as a Research Assistant at Vaagdevi Institute of Pharmaceutical Sciences (India)

(January 2022 -July 2022)

• Preparation of Transdermal patches and different dosage forms including Tablets.

• Evaluating different parameters including dissolution, disintegration, and friability of different dosages.

• Reviewing and re-evaluating the working formula.

• Record and maintain experimental records, assisted lab members in planning and performing experiments. PROJECT

• Regulatory Guidelines for New Drug Development in Vaagdevi College of Pharmacy (02/2021)

• Journal Publication (review article) in the Journal of Pharmaceutics and Pharmacology Research (2022) CERTIFICATIONS

• Lean Six Sigma Green Belt.

• Lean Six Sigma Yellow belt.

• Lean Six Sigma white belt.

• IATA certification

• Good Clinical Practice and ICH (GCP) (2023) CITI)

• Responsible Conduct of Research for Biomedical (2023) CITI)

• Information Privacy Security (IPS) (2023) CITI) Software skills

Microsoft Office including Word, Excel, Outlook, and PowerPoint, good computer skills.