Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Clinical Research Experience
Languages
Publications
Timeline
Generic

Stuti Sharma

Houston,Texas

Summary

I am a Foreign Medical healthcare professional years of hands on experince in various departments of clinical practice, both urban and rural, in many different countries. In the United States, I began my path as a clinical research professional, gaining experience in pharmacy operations, clinical research trial operations, clinical review, and quality improvement. With my vibrant cultural and educational background and a desire to grow and learn, I look forward to serving the healthcare industry and providing comprehensive patient care.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Clinical Project Manager

DM Clinical Research
04.2024 - Current
  • Organized and led cross-functional teams to manage the development, execution, and reporting of clinical studies.
  • Assessed study progress and identified potential risks or delays in order to develop strategies for mitigation.
  • Ensured compliance with SOPs while managing multiple projects simultaneously within budget constraints.
  • Monitored site performance metrics and took corrective action when necessary.

  • Created onboarding program and leaving materials for new staff members, training in clinical operations of clinical trials
  • Compiled data from various sources into meaningful reports; analyzed results obtained from clinical studies; provided recommendations based on findings reported therein.
  • Oversight and assesses 10+ Clinical Research sites and specialists
  • Training clinical research team members and evaluating their performance
  • Ensure Stakeholder Satisfaction
  • Works with the Site Director to identify training needs and organize training interventions to meet quality standards
  • Collaborates with the HR, Training, and Central Services team to evaluate training programs for site staff
  • Spearheaded clinical training and orientation for newly hired staff and retrianing for retention purpose
  • Managed resources efficiently across multiple project teams ensuring delivery according to quality standards set forth by clients.
  • Collaborated with healthcare professionals to deliver high-quality patient care.
  • Collaborates with members of the Training and Development team to maintain, revise, evaluate, and develop training material
  • Lead collaboration amongst departments to deliver standardized methods of clinical procedures across sites
  • Collaborate with the OD department for in-person mentoring programs for site employees
  • Collaborate with Site Management in leading and coordinating internal staff training sessions
  • Conducts and Coordinates training for sites to reduce quality-related problems and increase understanding of our culture of quality
  • Evaluated quality index scores and key performance indicators to identify opportunities for improvement.
  • Leads ongoing training efforts for staff based on needs found in performance evaluations, career development plans, performance improvement plans, and other plans set by management.
  • Coordinated investigator meetings as well as training sessions related to GCP and ICH guidelines and procedures.

Supervisor of Unblinded Clinical Research Department

DM Clincal Research
Housotn , TEXAS
08.2022 - 04.2024
  • Oversees and mentors multiple sites for DM Clinical Research
  • Directed and supervised and mentored team of 11 employees in daily operations.
  • Maintained accurate records of employee performance, attendance, leave requests, and disciplinary actions.
  • Interviewed applicants, recommended individuals for hiring and evaluated staff performance for IP management team for multiple locations
  • Ensured compliance with workplace safety regulations by providing training sessions for all staff members
  • Member of the SOP committee to create and amend appropriate official documents following ALCOA-C standards
  • Creating training content for the Unblinded team in collaboration with training and development departments for DM
  • Responsible for attending and preparing pre-SIV, SIV/uSIV,uIMV, COV and in-person IM
  • Directed and supervised team of 15 employees in daily operations.
  • Communication with the executive leader.

Lead Unblinded Clinical Research Coordinator

DM Clinical Resaerch
08.2021 - 08.2022
  • Comprehension and execution of clinical trial protocols following ICH-GCP guidelines and ALCOA-C principles
  • Collection of high-quality and credible data while protecting the rights, well-being, and safety of all participants
  • Investigational Product management, including drug accountability, storage, dispensation, preparation, and administration per protocol-specific guidelines
  • Administration of Investigation Products (vaccines and medications ) using ACIP best practices and protocol-specific guidelines to maintain the highest level of patient safety
  • Responsible for temperature monitoring and record maintenance of all IP storage equipment and devices in accordance with site SOPs and protocol-specific requirements
  • Create and maintained unblinded regulatory binders using Florence’s online eRegulatory program
  • Maintain impeccable source documentation and IP-related records both physically onsite and online.

Telemedicine Internal Medicine Physician

Aliveva Clinic
Bhopal , Madhya Pradesh
04.2021 - 12.2021
  • Worked as a detail-oriented and compassionate physician conducting remote medical care to patients via audio and video calls as well as written communications
  • Responsibilities included diagnosing and monitoring conditions, monitoring prescription medication usage, performing prescription renewals, and referring patients to other physicians or health care specialists as needed.

Clinical Research Screening Coordinator

DM Clinical Research
08.2021 - 08.2021
  • Initial contact with potential participants to evaluate their medical history and analyze traits based on the study protocol's various inclusion/exclusion criteria and forward cases to the Study Investigator
  • Maintained the study trackers and kept a record of ROI, MRs, and various lab reports for each subsequent visit for the specific trial's duration
  • Attended SIVs (Site Initiation Visits), following up with the patient’s health records and coordinating with the post-exposure events
  • Assisted studies include Pfizer RSV, Chikungunya, Rheumatoid Arthritis, Migraine, COVID-19, and Moderna RSV trials.

Aphasia Intern

Aphasia Recovery Center
07.2020 - 06.2021
  • Content creator for telehealth operations and provided supportive therapy for patients suffering from clinical aphasia post-brain strokes and other cerebral injuries.
  • Collaborated with team members to create a comprehensive strategies and presentations

Graduate Assistant

Texas Woman’s University
03.2020 - 05.2021
  • Assisted in research work with the supervisor
  • Managed and re-arranged data for the studies
  • Wrote literature review and IRB applications
  • Created study survey questionnaires for the participants.
  • Managed multiple tasks simultaneously while meeting deadlines under pressure.
  • Maintained an up-to-date knowledge of educational trends by reading scholarly journals.

Internal Medicine Physician

Bansal Hospital
11.2018 - 10.2019
  • Oversight and management of the outpatient as well as inpatient departments, including High Dependency Units (HDU) and Emergency Room (E.R.)
  • Managed patient detailed history taking, drug charts, and investigations; treatment protocol and follow-ups
  • Member of a Code Blue Team.

Internal Medicine Resident

Union Hospital
09.2015 - 06.2018
  • Trained in the IM department, in surgical and minimally invasive techniques such as bone marrow biopsies, endoscopies, colonoscopies, and bronchoscopies.
  • Provided comprehensive care for patients with acute and chronic medical conditions.
  • Performed physical examinations, ordered laboratory tests, and interpreted results.
  • Conducted rounds on inpatients to monitor progress and treatment plans.
  • Participated in interdisciplinary team meetings to discuss complex cases.

Junior Obstetrics & Gynecology Resident

Shekhar Hospital
08.2013 - 06.2014
  • Assisted nurses and medical staff to improve the safety, comfort, and care of patients
  • Assisted in normal birth deliveries, C-Sections, and procedures with a team of surgeons.
  • Conducted daily rounds to check on patients health and wellness and updating daily health charts
  • Responded quickly and appropriately to any medical or behavioral emergencies that arose.

Clinical Intern

People’s Medical College
04.2012 - 03.2013
  • Assisted the residents and consultants of various departments, including managing the ER
  • Mentored undergraduate students in medicine and gynecology
  • Maintained up-to-date records of patient progress notes.
  • Collaborated with other healthcare professionals to ensure quality care for all patients.
  • Educated families and caregivers about mental health issues and treatments.
  • Participated in weekly case conferences to discuss treatment plans and progress.
  • Assisted and observed surgical procedures on O.T Days
  • Attended various outreach camps.

Education

Master of Business Administration in Health Care Administration (MBA-HCA) -

Texas Woman’s University
01.2021

Doctor of Medicine-Internal Medicine (MD) -

Union Hospital, Tongji Medical College
01.2018

Bachelor of Medicine, Bachelor of Surgery (MBBS) -

People’s Medical College under Barkatullah University
01.2012

Skills

  • Clinical research trial operations
  • Pharmacy operations
  • Clinical project management
  • Project planning and development
  • GCP, IATA, HIPAA, BLS, ACLS, and Mental Health First Aider certifications
  • MCI Registration Certificate from Medical Council of India
  • Distinction in Ophthalmology certificate
  • Training and mentoring
  • Compliance Oversight

Certification

  • 2023 | GCP, IATA, and HIPPA Certification
  • 2022 | BLS and ACLS Certification DM Clinical Research
  • 2021 | Mental Health First Aider Certificate
  • 2013 | MCI Registration Certificate from Medical Council of India
  • 2009 | Certificate of Distinction in Ophthalmology

Accomplishments

  • Employee of the Year (2021-2022): Everyday Example of Excellence Award, DM Clinical Research, 01/2023
  • TCDD Employee of the Month, DM Clinical Research, 02/2022

Clinical Research Experience

  • Moderna Tx, INC.mRNA-1010-P101
  • Moderna Tx, INC.mRNA-1230-P101
  • Novavax 2019nCOV-301
  • Moderna Tx, INC.mRNA-1273-P301
  • Moderna Tx, INC.mRNA-1273-P204
  • Moderna Tx, INC.mRNA-1273-P205
  • Moderna Tx, INC.mRNA-1345-P301
  • Pfizer C4591001
  • Pfizer C4591031
  • Pfizer C3671013
  • Emergent EBSI-CV-317-004
  • Janssen Vaccine &Prevention B.V VAC31819COV3001
  • Janssen Vaccine & Prevention B. V VAC31819COV3009
  • Janssen Vaccine & Prevention B. V VAC31819RSV3001
  • Merck V110-911
  • Alnylam ALN-AGT-002
  • Mylan Inc.
  • Sanofi VAV00020
  • Sanofi VAV00029
  • GSK-SupernovaD000700001- Inf usion

Languages

  • ENGLISH – Native
  • HINDI – Native
  • URDU – Native
  • CHINESE – Conversation Fluent

Publications

  • Psychosocial Factors Associated with Irritable Bowel Syndrome Development in Chinese College Freshmen, Journal of Neurogastroenterology and Motility, 25(2), 233–240, https://doi.org/10.5056/jnm18028, Jiang, C., Xu, Y., Sharma, S., Zhang, L., Wang, H., Song, J., Qian, W., Bai, T., Hou, X., 2019
  • Association of defecation disorders with suicidal ideation in a young adult with chronic abdominal discomfort, Journal of Affective Disorders, 253, 308–311, https://doi.org/10.1016/j.jad.2019.05.004, Jiang, C., Xu, Y., Sharma, S., Zhang, L., Wang, H., Song, J., Qian, W., Bai, T., Hou, X., 2019
  • Fecal Microbiota Transplantation Is Effective in Relieving Visceral Hypersensitivity in a Postinfectious Model, BioMed Research International, 2018, 1-6, https://doi.org/10.1155/2018/3860743, Bai, T., Zhang, L., Wang, H., Qian, W., Song, J., Hou, X., 2018
  • The Hiatal Hernia Associated with Both Esophageal and Colonic Diverticulum, European Journal of Gastroenterology & Hepatology, 33, Luvsandagva, B., Bai, T., Sharma, S., Hou, X., 2018
  • Piezo2: A Candidate Biomarker for Visceral Hypersensitivity in Irritable Bowel Syndrome?, Journal of Neurogastroenterology and Motility, 23(3), 453–463, https://doi.org/10.5056/jnm16114, Bai, T., Li, Y., Xia, J., Jiang, Y., Zhang, L., Wang, H., Qian, W., Song, J., Hou, X., 2017
  • Diagnostic performance of confocal laser endomicroscopy for atrophy and gastric intestinal metaplasia: A meta-analysis, Journal of Digestive Diseases, 18(5), 273–282, https://doi.org/10.1111/1751-2980.12470, Bai, T., Zhang, L., Sharma, S., Jiang, Y. D., Xia, J., Wang, H., Qian, W., Song, J., Hou, X., 2017
  • The Influence Factors of Disease Conviction in IBS patients, Psychology, Health & Medicine, Jiang, X. H. C., Xu, Y., Sharma, S., Zhang, L., Wang, H., Song, J., Quan, W., Bai, T., 2016
  • Awareness And Knowledge of Blood Donation Among Medical Faculty And Students In Vadodara District, International Journal of Scientific Research, 3(10), 304–308, Vasisht, S., Sharma, S., Imrit, T. S., Mehta, V., 2014

Timeline

Clinical Project Manager

DM Clinical Research
04.2024 - Current

Supervisor of Unblinded Clinical Research Department

DM Clincal Research
08.2022 - 04.2024

Lead Unblinded Clinical Research Coordinator

DM Clinical Resaerch
08.2021 - 08.2022

Clinical Research Screening Coordinator

DM Clinical Research
08.2021 - 08.2021

Telemedicine Internal Medicine Physician

Aliveva Clinic
04.2021 - 12.2021

Aphasia Intern

Aphasia Recovery Center
07.2020 - 06.2021

Graduate Assistant

Texas Woman’s University
03.2020 - 05.2021

Internal Medicine Physician

Bansal Hospital
11.2018 - 10.2019

Internal Medicine Resident

Union Hospital
09.2015 - 06.2018

Junior Obstetrics & Gynecology Resident

Shekhar Hospital
08.2013 - 06.2014

Clinical Intern

People’s Medical College
04.2012 - 03.2013

Master of Business Administration in Health Care Administration (MBA-HCA) -

Texas Woman’s University

Doctor of Medicine-Internal Medicine (MD) -

Union Hospital, Tongji Medical College

Bachelor of Medicine, Bachelor of Surgery (MBBS) -

People’s Medical College under Barkatullah University

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