Clinical Research Assistant
Resume:
MUGDHA JAITPAL
937-***-**** adhu0d@r.postjobfree.com
https://www.linkedin.com/in/mugdha-jaitpal-55406538/ SUMMARY
Exceptionally organized and detail-oriented individual with skill set covering project and process management, planning, communication, and interpersonal skills developed from hands-on progressive experience in the healthcare and pharma industry. Self-motivated with strong leadership and communication skills.
PROFESSIONAL EXPERIENCE
Cincinnati Children’s Hospital Medical Centre, Neurology Department Cincinnati, USA Clinical Research Coordinator III Feb-May,2020
• Planned, organized and scheduled assessments,tests,activities to meet research objectives and study protocol compliance.
• Prepared and submitted timely, accurate, and complete documentation of study continuing review and study amendments to Institutional Review Board (IRB). Assisted investigators with reportable event submissions to IRB.
• Assisted with preparation of study documents such as informed consent, recruitment script, and other materials. Assisted with preparation of proposal, protocol, case report forms and progress notes, as needed. Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional regulations and policies.
• Up-to-date documented knowledge of federal research and clinical regulations (CITI, HIPAA, & GCP certifications).
• Prepared site for monitor visit and external/internal audits. Provides timely response to queries from sponsor and/or auditors.
• Advanced use of REDCap Database systems, particularly the ability to design and maintain large, complex projects.planning, communication, and interpersonal skills developed from hands-on progressive experience in the healthcare and pharma industry. Self-motivated with strong leadership and communication skills.
University of Utah, Neurology Department Utah, USA Clinical Research Coordinator Sep-Dec,2020
• Maintenance of regulatory master files for industry & investigator initiated clinical trials.
• Helped investigator in screening patients following the Inclusion & exclusion criteria.
• Recorded accurate and timely data onto case report forms,maintains source documentation for all case report entries.
• Documented and maintains all study-related procedures, processes and events, protocol deviations and exemptions and assisted with quality assurance.
• Worked as a Enrollment assistant for Threewire,Compliance Wire,Longboat in the patient recruitment for all clinical trial studies.
• Proficiency in preparing documents such as study binder,regulatory binder,patient binder.
• Managed patient data entry for all clinical trial studies through Medidata RAVE,iMedinet,etc.
• Managed all types of binders such as regulatory,patient,pharmacy binders for all clinical trials.
• Performed lab processing using centrifuge for serum samples.Centrifuged the PK samples and aliquoted,performed drug test and pregnancy test using urine sample of the patients.
• Managed patient data entry for all clinical trial studies through Medidata RAVE,iMedinet,etc. Wright State Physicians, Dermatology Department Dayton, USA Clinical Research Assistant 2018-2019
• Managed patient data entry for all clinical trial studies through Medidata RAVE,iMedinet,etc.
• Maintained all types of binders such as regulatory,lab data case report forms, patient,pharmacy binders for all clinical trials.
• Maintained lab kits and inventory for different studies of the clinical trials
• Supported and coordinated with clinical research coordinators from the study start up to close out.
Wright State University Dayton,USA
Technologist 2018-2019
• Helped and assisted students with disability to read and write various study materials.
• Worked on study materials of disable students to edit, scan and recognize using different softwares(Abbyfine reader) which help them in understanding the material clearly and easily. GlaxoSmithKline Pharmaceuticals Ltd. Mumbai, INDIA Medical Business Associate 2011–2017
• Promoted range of products such as antibiotics, anticoagulants, antifungals to the medical consultants, paramedical staff across different hospitals.
• Established and fostered relationships with key influencers like doctors, RMO’s, paramedical staff etc.
• Developed viable business relationships with medical professionals and reported adverse events to pharmacovigilance team based in UK.
• Trained sales team in strategic communications on existing and new product launches, successfully launched two new products (Arixtra and Mycamine) among 200+ health care specialist.
• Achieved targets by developing go to market strategy, competitive analysis and identifying key opinion leaders in the hospitals.
• Designed promotional brochures, newsletter and strategic communications for health care providers for brand promotion.
• Appropriately engaged customers based on segment to establish and maintain value-based relationships.
• Awarded as highest seller for Arixtra (fondaparinux)-7.5mg injectables across India among hospital business team in India.
EDUCATION
Master of Science in Pharmacology and Toxicology(3.79/4) Boonshift School of Medicine, USA, 2017-2019.
Bachelor’s Degree, Pharmacy
University of Pune, Mumbai, 2007-2011. (First Class with distinction) RESEARCH EXPERIENCE
Laboratory techniques: Cell culture technique, mating type PCR, immunohistochemistry,western blot, etc.
Equipments :Biotek real time PCR machine, Chemidoc MP, Biotek plate reader,Centrifuge. Softwares skills:Microsoft Office, Minitab, Adobe Acrobat Reader,Graphpad prism. Related coursework and Training
Courses:Human Studies Research, Six Sigma Green Belt, Leadership Theory and its Application, Cellular Pharmacology and Toxicology, Effective Scientific Writing, Biokinetics and Biodynamics, Pharmacology Journal Club, Biostatistics, Laboratory Management, Laboratory Safety. Trainings and Certifications: Medidata RAVE, iMedinet, Redcap database, EPIC, EDC, CITI, ICH-GCP, Lean Green and Black Belt Six Sigma Certification.
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