CLINICAL RESEARCH/ REGULATORY/ MEDICAL TECHNOLOGY QUALITY Resume
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Resume:
Summary
- • years of experience as Clinical Research Coordinator / Pharmacy Intern.
- • Energetic and passionate student working towards a Master of Science in Applied Clinical Research at St. Cloud state university.
- • Extensive project experience from concept to development with areas of expertise include writing protocols, assessing and monitoring serious adverse effects, preparing clinical study, safety and compliance reports.
- • Worked in assisting design, schedule and data process for a pharmacokinetic and pharmacodynamic study.
- • Collaborated with the Principal Investigator to respond to audit findings and implement approved recommendations. Have a good knowledge of institutional animal care and use committee protocol, ICH/GCP Guidelines, medical terminologies and code of federal regulations for human subjects.
Education
- • Master of Science in Applied Clinical Research, St. Cloud State University – St. Cloud, MN, USA
Currently Pursuing – anticipated
Projects:
Device Development plan for a Smart Deep Brain Stimulator
Clinical effect analysis (CEA) of a Pacemaker
- • Doctor of Pharmacy (Pharm.D.): , Sri Ramachandra University - Chennai, INDIA
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Publications:
A systematic review of second-line controller combination therapy options for the management of asthma.
Link: https://link.springer.com/article/./s---
Projects:
Titled “Assessment of Relapse Rate in Alcohol Dependence Syndrome Patients (psychiatric) with and without treatment of Disulfiram”.
Skills
- • Serious Adverse Event (SAE) reporting
- • Thorough knowledge of FDA, ICH/GCP, GMP, PMAA, Medical Device Directive principles and regulations, HIPAA
- • Documenting and assisting in clinical research and trials, CAPA review for audit responses
- • Statistical Analysis (Biostatistics), Data Monitoring and Data Integrity
- • Knows, understands and abides by the components of the FAIR Shake and by SOPs.
- • QSRs, ISO , MDR, MDSAP, international regulations, PMAs, (k)s and IDE Regulations
- • Strong analytical, research, trial preparation skills, and compliance advice skills
- • Medical Terminologies and PMS
- • Therapeutic and protocol knowledge
- • Subject Recruitment, Screening and Data management
- • Good communication, IT & administrative skills
- • Willingness to adapt and learn, with kindness.
Work Experience
CLINICAL RESEARCH COORDINATOR, to Sri Ramachandra Medical College and Research Institute – Chennai, INDIA
Worked with WHO team as a Clinical Research Coordinator (CRC) in the study entitled 'An open-labeled, randomized, multicenter, comparative study to evaluate the immunogenicity and reactogenicity of inactivated polio vaccine (Panacea Biotec Ltd.) with imovax polio (Sanofi Pasteur India Pvt Ltd) in infants'.
- • Contribution to the collection, compilation, documentation, and analysis of this clinical research which led to determining the effectiveness of the polio vaccine.
- • Responded effectively to protocol violations and afforded lab reports and pharmacist analysis.
- • Collected, reviewed, analyzed and maintained regulatory documents and performed IRB submissions.
- • Monitored data expeditiously to reduce data discrepancies; collaborated with both the sites and data
- • Ensured compliance with the CRF's and protocols, assisted in developing the standard operating procedure.
- • Reviewed essential/regulatory documents, ensuring Investigator Site Files (ISF) are accurate, current and identical to Trial Master File &#;TMF&#;
- • Prepared and Provided timely reporting of subject safety, adverse events (AEs), serious adverse events (SAEs) and protocol violations to sponsor and IRB
- • Assisted in on-site monitoring of clinical trials including the review of source documentation, development of protocols, case report forms (CRF), regulatory materials and drug accountability
- • Maintained working knowledge of all applicable FDA regulations and ensure compliance with current FDA
- • Regularly performed Investigator Product Accountability during monitoring visits
- • Maintained database of patient’s information, analyzed data collected from patients during the clinical research trial. Established and maintained trial master files in digital and physical formats
- • Performed site initiation, subject recruiting and routine monitoring.
PHARMACY INTERN, to Sri Ramachandra Medical College and Research Institute – Chennai, INDIA
Preparing and dispensing prescribed drugs and medicines, while also maintaining pharmacy supplies and records. Prepare, control and issue pharmaceutical products, also evaluate orders to verify dosage, dosage regimen, and quantity to be dispensed. Instructions to patients regarding medication consumption and side effects. Perform quality control checks on medications.
- • Prescription dispensing/compounding, Inventory control, Product safety, Patient counseling, Tablet dilution for Pediatrics, Total Parenteral Nutrition (TPN) for Neonatal Intensive Care Unit (NICU).
- • Dosage calculations for Oncology patients of any age group, Antibiotic auditing, ADR's processing, and reporting, Drug Therapy Decision Making with sound knowledge on Interpretation of Laboratory Investigations. Design suitable Pharmacotherapeutic Regimens for the patients by retrieving and integrating patient data.
- • Worked in ambulatory/outpatient environment and inpatient/hospital setting. Focused on Drug and Poison Information Centre (DPIC) for answering emergency calls and suggest plans for handling exposures to toxins, chemicals or life-threatening drug interactions by providing up to date information about drugs, poisoning, and its toxicology. Worked in the area of Pharmacovigilance. Molded me in providing Discharge Counseling on medications, diet and lifestyle modifications for the inpatients.
Certifications
- • GCP (Good Clinical Practice) - Regulatory affairs and Medical Technology Quality Certification.
Additional Information
HONORS AND AWARDS : Awarded Second place for Presenting a Poster/Paper on ADR Monitoring. : Awarded First place for Presenting a Case on Drug-induced Rheumatoid Arthritis and Osteoporosis.
POSTER/PAPER PRESENTATIONS : Presented poster on ADR Monitoring at Sri Ramachandra University, Chennai, Tamilnadu, India. : Presentation on Medication Errors at PSG Institute of Medical Sciences and Research, Coimbatore, Tamilnadu, India.
COMMUNITY SERVICES Volunteered and participated in Eye Donation Camps, Diabetic Awareness Rally, Urban and Rural Health Camps, Eye Donation Fortnight Program.
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