Samta Rastogi M.D.

Chantilly, VA ***** Mobile - 571-***-****

adhoyj@r.postjobfree.com

U.S. Citizen, No Visa Sponsorship Required

MEDICAL EDUCATION

The following degrees have been evaluated as the US equivalency summary as Three years of graduate medical education and First professional degree in medicine (Doctor of Medicine) by World Education Services, Inc.’’

ALLAHABAD UNIVERSITY, India May 2003 May 2006

MOTI LAL NEHRU MEDICAL COLLEGE

● Master of Surgery, Human Anatomy (M.S.)

GORAKHPUR UNIVERSITY, India Feb 1996 October 2000

B.R.D. MEDICAL COLLEGE

● Bachelor of Medicine and Bachelor of Surgery (M.B.B.S.)

Permanent Registration Number for M.B.B.S. – 046664 (Recognized by Medical council of India)

Objective

4 years of experience in Clinical Data Management, executed data management related activities across multiple clinical trials as a therapeutic program lead. Provides technical and operational expertise to the data project teams and is responsible for ensuring the clinical data collected meets the requirements of the clinical study objectives for the purpose of clinical study reports, publications, and regulatory submissions. Demonstrated proficiency to lead and coordinate with cross functions for multiple assigned projects related to planning, execution, collection, and cleaning of clinical data; and focus on timely quality delivery as well as consistency across the data management components. Determined to implement earned skills and knowledge for the rapid growth of the prospective organization by working effectively and consistently.

PROFESSIONAL EXPERIENCE

Clinical Data Manager II (Contractor)

April 2018- Present

National Cancer Institute, NIH Bethesda, MD

Collecting data from medical research projects, such as clinical and pharmaceutical trials. Worked with Experimental Transplantation and Immunology Branch.

●Working experience for CCR Sponsored Phase 1 Clinical trials, CAR- T Cell transplantation malignancies such as Lymphoma, Multiple Myeloma, Cervical Cancer and nonmalignant conditions such Recurrent Respiratory Papillomatosis and Vulvar High Grade Squamous Intraepithelial Lesions.

Working experience for Celgene corporation, a Biopharmaceutical company on ‘’A Phase 1 study of BCMA- expressing Multiple Myeloma’’ and ‘’ A Long term Follow up Protocol for subjects treated with Gene Modified T cells.’’

Compliance with NIH IRB policies and procedures

Preparing Regulatory reports (Continue Review reports, SMC) for FDA, IRB and data charts.

Working experience in data management software (e.g. Medidata Rave, Oracle Clinical EDC, e- caselink Database)

Performing quality assurance activities to ensure protocol requirements are met for submissions to the IRB.

Carefully documenting in writing any discrepancies identified during data validation activities.

Ensure documentation and management of clinical study data is in accordance with regulations.

Develop and implement the data correction process, discrepancy resolution.

Identify inclusion or exclusion criteria to read medical charts and enter new subject data.

Collect and manage patient and laboratory data for clinical research projects.

Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.

Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.

Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.

Prepare data summaries, assist with data analysis, abstract and manuscript preparation.

Ensuring the confidentiality, security, and accuracy of data in accordance with federal and institution regulations.

Submit IRB applications for annual continuing review, extract study data from source documents and electronic medical records, complete data entry into electronic data capture systems, and maintain and create regulatory documents for cooperative group trials.

Preparing and updating concomitant medications and adverse events logs.

Assist in extracting protocol required source data from CRIS electronic medical records.

Assist in preparing for the monitoring visit.

Trained in HIPAA Privacy Rule, Biosafety, CRIS electronic medical record system.

Simulation Lab Technician, School of Nursing

October 2017- December 2017

George Washington University, Ashburn, VA

Coordinate with set up of Clinical Simulation Lab and maintenance of all simulation/ practice equipment as on need basis.

Ensure compliance with QSEN (Quality and Safety Standards for Nurses).

Prepare and oversee instructional laboratory simulation sessions in all areas of clinical nursing skills

Promote and maintain a professional learning environment.

Clinical Data Analyst/ Annotator, Bioinformatics Center

Nov. 2016- August 2017

George Washington University, Washington, DC

Clinical Data analysis.

Annotation of Pathology reports of Cancer cases.

Assistance in Research work

Faculty Pharmacy, Pharmacy Technician Program

November 2015- June 2016

Metropolitan Institute of Health and Technology, Lorton, VA

Coordinate and supervise the Pharmacy Technician program in accordance with the philosophy of the institute.

Maintain up to date academic records on each student and make these records available to the Office of Admissions and Records.

Plan and arrange Advisory Committee meetings and work with the members of the committee to ensure that the program has adequate resources and a well design curriculum to provide students with the knowledge, skills, and abilities essential for employment.

Professor Anatomy, Medical Assistant Program

January 2016 -March 2016

Westwood College, Arlington, VA

Instruct and implement courses in compliance with the curriculum standards and objectives.

Teach one or more courses within the syllabi requirements.

Implement daily lesson plans for students to include scheduled activities and course materials.

Clinical Research Coordinator June 2014-October 2014

Nova Health Management & Research Group PC, Sterling, VA

Reviewed and developed a familiarity with the protocol, e.g., study proceedings and timelines, communication and protocol management.

Assistant Professor, Department of Anatomy

May 2008 – July 2013

G.S.V.M. MEDICAL COLLEGE, KANPUR, India

Designed and delivered lectures to 195 First year medical undergraduate students and 6 graduate students. Active participation in Seminar Conduction of graduate students, taking responsibility of Seminar in charge of the Anatomy department.

Internal assessment of students in form of Part completion test, part completion viva.

Utilized evidence base medicine via journal articles and research publications to strengthen teaching of Human Anatomy.

ADMINISTRATIVE DUTIES

Office in charge of departmental library of Anatomy

Office in charge of dissection hall of Anatomy Department

Actively participated in all cultural/extracurricular activities/ Social functions/Sports/Community and Extension services.

ROHILKHAND MEDICAL COLLEGE

Nov 2006 – May 2007

BAREILLY, India

Assistant Professor, Dept. of Anatomy

Lecturer, Department of Anatomy

July 2006 – Nov 2006

ERA MEDICAL COLLEGE AND HOSPITAL, LUCKNOW, India,

Junior Resident, Department of Anatomy

May 2003 – May 2006

MOTI LAL NEHRU MEDICAL COLLEGE, ALLAHABAD, India

Shared, learnt and nurtured in a rigorous yet team environment, dedicated to extensive teaching of Gross Anatomy, Histology, Embryology, Clinical Anatomy, Radiological Anatomy, Cadaver dissection, Surface Anatomy.

Intern, Compulsory Rotatory Internship after MBBS

Nov 2000 May 2002

Nehru Hospital, BRD Medical College, Gorakhpur, India.

Collected systemic history, performed relevant physical examination, ordered and interpreted lab investigations, prepared differential diagnosis, counseled patients and prescribed treatment modalities in both outpatient and inpatient settings.

Skills and Competence

Experience working in the healthcare environment and interacting with patients.

Possess good knowledge of medical terminology and procedures.

Strong organizational skills, sense of accuracy and attention in details.

Strong independent as well as a team player and able to handle tight deadlines.

Knowledge of Good Clinical Practice (GCP), FDA and ICH regulations, IND (Investigational New Drug Application).

Familiar with Clinical Trial Phases and Design, roles and responsibilities of IRB’s, Investigators, CRO’s and Sponsors.

Knowledge of regulation of CAR T Cells/ Immunotherapy and clinical trials.

Knowledge of Clinical Trial Protocol, Electronic Data Capture (EDC), and Case Report Forms (CRF).

Data Management Plan development, database setup and validation.

Knowledge and experience in data management software (e.g. Medidata Rave, Oracle Clinical, e- caselink)

Knowledge of the SQL used SQL queries to validate data in the back end.

Knowledge on the process and documentation of informed consent form.

Knowledge of Quality Analysis, Inspection readiness.

Developing and finalizing CSR (Clinical Study Report).

Professional Membership

Life member of Anatomical Society of India and Anatomical Society of UP Chapter.

Certificates/Licensure/ Training

Collaborative Institutional Training Initiative & Good Clinical Practice and Biomedical 101.

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