Muhammad (Umer) Choudhry M.D., M.S. Email & Phone Number

White Oak, Maryland, United States

- Develop expert-level clinical quality systems/procedures for QA guidance and to support clinical activities.- Actively collaborate with multidisciplinary teams to provide Good Clinical Practices (GCP) guidance during all phases of investigational drug development.- Provide expert review on regulatory and clinical documents for accuracy and internal consistency including Clinical Study Protocol, Clinical Study Report, Development Safety Update Report, and Investigator Brochure.- Conducts investigations of complex clinical GCP and safety-related issues and creates corrective action plans.- Reviews and provides comments on all the documents for the final IND submissions.- Develops and successfully implements an oversight plan for each clinical trial.- Ensures clinical trials are conducted in accordance with the protocol and, in compliance with guidelines and regulatory requirements for inspection readiness in collaboration with Clinical Operations, Regulatory Affairs, and other stakeholders.- Leads or co-audits vendors, internal and external systems, and clinical sites.- Develops QA plans and contributes to risk assessment activities.- Promotes and advances quality awareness throughout the organization by providing GCP training.- Administers and maintains Quality Management Systems, including: change management, deviation management, document control, records management, and GXP training management.

Washington, District Of Columbia

- Performed Internal Quality Audits and provided assistance with CAPA (Corrective and Preventive Actions), quality assurance and compliance per institutional and federal regulations.- Planned, managed and implemented the quality management and quality improvement programs at Georgetown University.- Provided consultation and direction to ensure that studies are conducted in accordance with sponsor protocols, GCP (Good Clinical Practice), industry guidelines, agency regulations.- Assisted with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or industry standards where applicable.- Supported in maintaining the highest standards across all clinical research departments at Georgetown University by providing or coordinating training (e.g. GCP, Safety Monitoring).- Ensured Data & Safety Monitoring Committee (DSMC) activities comply with all National Cancer Institute (NCI) expectations by tracking data in proprietary systems, auditing selected DSMC studies on a quarterly basis and providing guidance on issues related to DSMC regulations and actions. - Created standard operating procedures for research purposes at Georgetown University.

Washington D.C. Metro Area

- Supervised and trained Hematology-Oncology and Phase1 clinical trial data management teams to implement clinical data management SOP’s and policies to facilitate study process of more than 50 studies.- Monitored internally every month all National Clinical Trials Network trials, which include Alliance, Eastern Cooperative Oncology Group & the American College of Radiology Imaging Network and Southwest Oncology Group to ensure timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.- Conducted study close out visits and assist in study site initiation visits.- Collaborated closely with study Principal Investigators, Quality Assurance and Clinical Research Coordinator’s to maintain clinical Protocol integrity in preparation of Sponsor and FDA Audits.- Overseen the project specific clinical database design, creation and testing as well as development and implantation of data validation with checks and query programs.- Assisted Quality Assurance on sponsor qualification, protocol deviations, Corrective and Preventive Action Plan implementation and meet all regulatory requirements.- Tracked specific activities of clinical study participants proactively to identify trial-related issues that may result in potential deviations and non-compliance through OnCore Clinical Trial Management System.- Prepared and commented on monitoring response letters from sponsor, cooperative and investigator initiative clinical trials.

Washington D.C. Metro Area

- Interacted with Pharmaceutical Sponsors, Auditors, Study Monitors and various departments at Georgetown Medical Center and other facilities on as needed basis.- Independently collected, prepared, organized and reconciled data for more than 15 Hem/Oncology clinical trials from multiple sources and management of patient’s data into databases.- Exceptional knowledge of all Electronic Data Capturing systems, which includes, OnCore, Medidata Rave, Oracle, InForm, Datalabs, Bioclinica, eClinical.- Ensured all adverse events appropriately documented in the medical records and are properly graded (for severity) using the appropriate version of National Cancer Institute (NCI) common toxicity criteria or protocol specific grading scales.- Worked closely with the Clinical Research Support Lab to ensure proper collection, handling, processing and shipping of all clinical research lab samples.

Washington D.C. Metro Area

- Accomplished long term culturing, isolation and immunogenic characterization of Primary Human Amniotic epithelial cells, test and validate their regenerative abilities in 2D and 3D system in collaboration with Center for Translational Transplant Medicine and Islet Cell Laboratory Medstar Georgetown University Hospital.- Efficient in isolation, establishing cell lines and bio-molecular characterization of human liver stem cells to use for personalized medicine in collaboration with Center for Translational Transplant Medicine MedStar Georgetown Transplant Institute. - Experienced in utilizing experimental and computational approaches for pre-clinical validation of a novel drug in various primary and commercial cell lines. - Optimized CRISPR/Cas system to knockout genes in primary human cell lines to analyze cell behavior.- Proficient using In Vivo Imaging System (IVIS) to studying epithelial-mesenchymal transition changes before and after injecting primary normal/tumor human cell lines orthotopically in animals and analyze data for cell growth, metastatic ability and morphological changes.- Successfully completed medulloblastoma project in which we showed paradoxical effect of p53 gene on the human medulloblastoma cells against chemotherapeutic stress.

Washington D.C. Metro Area

- Expert in processing human primary tumor tissue and established cell line by using Conditionally Reprogrammed Cell (CRC) method (developed by Dr. Schlegel and group). - Effectively became a part of team to complete a prostate cancer project, in which induction of the p53 tumor suppressor gene regulate cell death.

Silver Spring, Maryland

- Ensured patients were receiving the proper medical care; reviewed clinical records to develop an opinion of the effectiveness of the treatment and to ensure that records are properly maintained. - Performed non-invasive physical examinations along with medical history, presented weekly clinical case, discussed diagnoses, patient management and follow up.

Baltimore, Maryland

- Reviewed progress notes and laboratory reports to provide recommendations.- Actively participates in improving patient compliance with treatment.

Medicine Department

- Directed and initiated the diagnostic and therapeutic procedures involved in the examination, treatment and care of the full range of patients and assisting in subsequent day to day hospital care.

Department Of Dermatology

- Managed all patients, took complete history, conducted physical examination, Electrical Cauterization, UVA/UVB phototherapy.- Carried out round orders, ordered laboratory investigations, formulated discharged summaries and arranged follow up medical appointments.

Department Of Pediatric Surgery

- Pre and Post operative management of patients, and carrying out round orders.- Attended out- patient clinics and assisted in operations/procedures and case presentations

Executive Master'S In Clinical Quality, Safety & Leadership, Patient Safety And Quality, 3.912 Gpa (Magna Cum Laude)

Certified Clinical Trial Project Manager Ccpm

Bachelor Of Medicine, Bachelor Of Surgery (Mbbs), Medicine

United States Medical Licensing Examination (Usmle), Medicine

Doctor of Medicine (MD)