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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLE EMAIL AVAILABLE Miami, FloridaSummary:Experienced clinical research professional with ability in site initiation, monitoring, close-out, and clinical trials.Skilled in various study designs including randomized, blinded, parallel, biosimilar, and comparative studies.Proficient in generating source documents, delegation logs, manuals, and PowerPoint presentations tailored to study requirements.Conducted monitoring visits, collected, and overseen regulatory documentation to ensure protocol adherence and compliance with local regulations.Provided regular study updates to the team and documented deviation forms for any study changes.Involved in the query initiation process and resolution process, facilitated presentations on clinical studies, trained principal investigators, and guided them through study procedures and protocols.Skilled in creating delegation logs, manuals, deviation forms, overseeing case report forms (CRFs),Experienced in using IWRS (Interactive Web Response System) for randomization and drug supply management, for managing the entire clinical trial lifecycle.Possess comprehensive knowledge of regulatory guidelines such as ICH E2A, ICH E6 (R2), 21 CFR parts 610, 1271, 210, and 211, 45 CFR 46.116 as well as GxP guidelines.Experience:August 2020- July 2022CLINICAL RESEARCH ASSOCIATE in Axis Clinicals Ltd, Hyderabad, India.Worked in randomized studies, blinded studies, parallel studies/bio similar studies, comparative studies.Facilitated investigator study site selection and streamlined study start-up procedures.Conducted monitoring visits to ensure protocol compliance, evaluated the competence of study personnel, upheld "Good Clinical Practice," and performed close-out visits.Collaboration with site managers and took part in investigator meetings and training sessions to make sure that they are aware of the study protocol and requirements.Evaluated site performance, verified informed consent, protecting subject confidentiality, managed protocol deviations by conducting both on-site and remote monitoring activities, and devised corrective plans based on monitoring reports.Conducted investigative site file reconciliation, ensuring the completeness and consistency of essential and nonessential documents, while adhering to local regulatory requirements, ICH-GCP guidelines (ICH E2A, ICH E6 (R2)), project SOPs, and sponsor specifications.Performed source document verification, overseen drug accountability and storage compliance, and ensured regulatory requirements, IP inventory and reconciliation, query resolution, and documentation of activities.Experienced in using IWRS (Interactive Web Response System) for patient randomization, drug dispensation, and inventory management, for study planning, tracking progress, managing study sites, monitoring patient recruitment, and overseeing regulatory documentation.CRF (Case Report Form) during the study collecting all the necessary data from trial participants as specified by the study protocol including information about patient demographics, medical history, treatment administration, and outcomes.Responded promptly to inquiries from investigative sites.Provided regular study status updates to team members and project management, reported deviation forms for any change in the study and actively engaged in issue resolution to facilitate project timelines.Directed, coordinated, and supervised the daily activities of clinical study.Nov2019 - August 2020:Trainee Research Associate in Axis Clinicals Ltd, Hyderabad, IndiaAided in the planning, initiation, and execution of clinical trials, guided by fellow senior researchers and project managers using IWRS.Gathered, recorded, and managed data from clinical trials and research studies while ensuring compliance with protocols and regulatory requirements.Maintained strict adherence to study protocols and procedures throughout the trial phases, and maintained detailed documentation of study activities, examined case report forms (CRFs), source documentation, and other trial-related documents.Contributed to ensuring that all research activities met quality standards and regulatory guidelines such as ICH E2A, ICH E6 (R2), 21 CFR parts 610, 1271, 210, and 211 Good Clinical Practice (GCP).Additionally, prepared study reports, presentations, and regulatory submissions.Collaborated effectively with multidisciplinary teams, communicated study progress, and actively contributed to team meetings.Engaged proactively in training and development opportunities to enhance my research skills and deepen my understanding of industry regulations and guidelines.Apr 2019 October 2019CLINICAL PHARMACIST Intern in Malla Reddy Narayana Multispecialty Hospital, Hyderabad, IndiaCommunicated with patients to collect information about prescriptions and medical conditions or arrange consultations with pharmacists.Evaluated patient histories to assess medication compliance and spot issues such as Adverse Drug Reactions (ADR) and side effects.Interacted and Educated patients on drug interactions, potential side effects, and best methods of administration.Counseled patients on new medications and Over the Counter (OTC) products and follow up procedures to make sure that patients have recovered completely.Followed department policies, procedures, and best practices for pharmacy operations.Maintained patient records and suggested physicians the methods to overcome ADR and side effects of drugs.October 2018 - Mar 2019CLINICAL PHARMACIST INTERN St. Theresa's Hospital, Hyderabad, IndiaParticipated in medical camps and helped patients with medical conditions.Participated in ward rounds, assessed patient conditions, and determined proper medication therapy to issue.Communicated closely with patients, ensuring medical information was kept private.Educated patients on medication therapy, proper nutrition, and fitness.Advised patients on medication side effects and contraindications and explained proper administration.Performed regular follow ups on patients recovery after a proper prescribed medication.Projects:Research project: STUDY OF CLINICO-EPIDEMIOLOGY AND MANAGEMENT PRACTICES OF BACTERIAL VAGINOSISBacterial vaginosis is an infection in the vaginal region caused due to shift in microflora. Untreated vaginosis can often lead to severe complications such as pelvic inflammatory disease, cervicitis, salpingitis, endometritis, infertility, ectopic pregnancy, and preterm delivery This study therefore, aimed to determine clinico-epidemiology and management practices of Bacterial vaginosis.This project included data collection and statistical analysis tools such as SPSS. My role in this project is designing the inclusion and exclusion criteria, collecting samples from patients performing the tests such as and pH test, whiffs test, grams staining for clue cell determination and Nugent scoring followed by data analysis.THESIS: A PROSPECTIVE OBSERVATIONAL STUDY ON PRESCRIPTION PATTERNS FOR MEDICAL CONDITIONS DURING PREGNANCY IN A TERTIARY CARE TEACHING HOSPITALDrugs play a key role in improving human health and promoting well-being. However, to produce the desired effect, they must be safe, efficacious and must be used rationally. In general, drugs unless necessary should not be used during pregnancy because drugs taken by a pregnant woman can reach the fetus and harm it by crossing the placenta, the same route taken by oxygen and nutrients, which are needed for the growth and development of fetus. Prescribing medications during pregnancy is a complex task and takes many factors into account. The main factor which needs to be considered are the physiological changes which are associated during pregnancy, their effect on drug's pharmacology and the impact of these drugs on the benefits and risks in treatment of mother and the growing fetus. This situation becomes even more important and complicated when pregnancy is associated with comorbid conditions. There is more need and emphasis on education of women during pregnancy. Education about drug utilization, self-medication practices and appropriate usage of drugs during pregnancy is necessary for overall wellbeing of maternal health and the fetus. The need for education and counseling is even more among the illiterate women and those who belong to lower socio-economic class.Designed the inclusion and exclusion criteria, prepared case report forms, collected data from participants and done data analysis using SPSS.Skills:Regulations: ICH E2A, ICH E6 (R2), 21 CFR parts 610, 1271, 210, and 211, as well as GxP guidelines.Applications: DocuSign, IWRS, CTMS, Excel Spreadsheets, MS Office, Delegation logs, CRF, eCRFOther: Maintaining Patient Records, Electronic Health Records (EHR) and Electronic Medical Records (EMR), Data Entry, Review Case Reports, Protocols and Deviations, Drug Inventory Control, Project management.Education:MASTERS DEGREEIn Healthcare Informatics SACRED HEART UNIVERSITY GPA: 3.6BACHELORS DEGREEIn Doctor of Pharmacy OSMANIA UNIVERSITY GPA: 3.5License:Clinical Pharmacist from PHARMACY COUNCIL OF INDIA, issued in Oct 2022Publications:Research Article:A Prospective Observational Study on Understanding and Awareness in Pregnant women with Comorbid conditions in a Tertiary Care Teaching HospitalResearch & Reviews: Journal of Hospital and Clinical PharmacyA Prospective Observational Study on Prescription Patterns for Medical Conditions During Pregnancy in a Tertiary care Teaching HospitalInternational Journal of Pharmacy Practice & Drug Research |
