Manager Data

NITAL SONI

** ****** ****** ****, **********, N.J 08854? 973-***-****?

***********@*****.***

SUMMARY

10+ years of experience in implementing all phases of Oncology trials using

leading

Electronic Medical Records

Well versed in multiple Therapeutic areas - Cardio-Vascular, Endocrinology,

Oncology, Orthopedic, Neurology

Skilled in data management methodologies including data capture, analysis,

and validation

Expertise in regulatory standards such as FDA - GxP's (cGMP, GLP, GCP),

OHRP, HIPAA, 21 CFR Part 11

EDUCATION

? MS, Biomedical Informatics ?

BS, Medicine

Univ. of Medicine and Dentistry of New Jersey

Mumbai University

TECHNICAL SKILLS

Mosaiq, Sunrise Disease manager, Aria, SCM, Nextgen, File Maker Pro,

Oncore, Excel, Patient Secure

EXPERIENCE

Maimonides Cancer Center

April 2010- present

Medical information and clinical research specialist

. Lead the implementation of clinical trials to ensure accurate input

of protocol instructions into CPOE (computerized protocol order entry)

to produce accurate patient orders (lab and chemo, premeds), flow

sheets and follow-up appointments

Create and maintain a cancer treatment regimen library with 300+

regimens to treat different cancer categories. Each regimen has the

following components: chemotherapy agents, the associated supportive

care agents, hydration fluids, recommended lab and diagnostic tests,

CTCAE toxicities, clinical research references, and an integrated

chemotherapy-specific clinical decision support

. Maintain a database of all clinical trials; enter trial details,

eligibility, contract information, IRB records, and amendment

information in the clinical trial management module

. Enroll and update patients in the clinical trial management system.

Track new patients and screen them for eligibility

. Maintain a centralized repository of protocols, amendments, consent

forms, study questionnaires and other protocol specific documents

. Design clinical templates for physicians and nurses to incorporate

capture of trial specific data

. Hands-On training to the members of the research team (physicians,

nurses, coordinators) in electronic clinical trial. Training users on

data capture in Electronic data capture application. Create training

manuals for each user group.

. Developing SOPs for procedures to be followed for electronic clinical

trials as per regulations

. Prepare in-house CRF, study specific tools (eligibility checklists,

flow sheet, medication diaries, billing grids, patient calendars)

. Ensure accurate billing by defining billing designation (standard of

care or study cost) upon protocol creation at the procedure or visit

level so that the charges are accurately captured

. Maintain and run Clinical Trial Study Reports, safety, eligibility,

enrollment and data consistency, medication usage reports

. Maintain patient education materials and chemotherapy education

Cancer institute of New Jersey, UMDJ Oct

2006-April 2010

Oncology Informatics Specialist

. Responsible in developing, maintaining and supporting electronic

version of Clinical trials in SDM (CINJ's Electronic Medical Record

system). Enter and edit new clinical trial research protocols

/amendments according to protocol specifications and input patient

orders into EMR. This includes but not limited to, protocol-specific

flow sheets, treatment plans, required procedures, medication

administration records and physician notes in electronic medical

record system which is utilized for patient care, chemotherapy and

other treatment

. Creating study specific tools: medication diaries, eligibility

checklists, calendars, flow sheets, protocol specific calendars, in-

house CRF/E-CRF's. Build constraints for data entry in eCRF to ensure

accuracy and consistency

. Developed sops, policies and procedures for the handling of patient

data. Created Data Completion Guidelines for case report form (CRF)

completion.

. Hands-On training to the members of the research team in electronic

clinical trials trough use of

Oncology clinical information systems like Oncore (Oncology

research data capture application)

and sunrise disease manager (electronic medical record and

CPOE)

. Served on the data and safety monitoring committee. Prepare meeting

agenda, meeting minutes and communicating with the physicians about

the recommendations made by review committee. Prepare reports required

for CINJ data and safety monitoring.

. Perform on-going audits to ensure adherence to protocols, policies and

procedures while safeguarding patient confidentiality.

Review data for completeness and accuracy. Send data

queries to the study coordinators

. Served as a scientific review board coordinator. The main

responsibilities included were to assist investigators with submission

and approval of new trials through the scientific review committee.

This included coordinating the SRB meetings, planning the agenda,

taking meeting minutes, noting the group's recommendations and

communicating back to the investigators. Making sure the

recommendations were addressed before the new trials were approved.

Facilitated development of ePRMS (electronic Protocol Review and

Monitoring System portal) in ONCORE.

Cancer institute of New Jersey, UMDJ

June 2004 - Sep 2006

Clinical Research Review Specialist

. Responsible for initiating, coordinating, managing and closing

clinical trials (phase I -III) for NIH, Cooperative groups,

pharmaceutical industry as well as in-house studies

. Served as a Study liaison with study sponsors (including large

pharmaceutical companies). Facilitated site visits, monitoring visits

and conference calls

Responsible for the extrapolation, collection, compilation and

submission of data including patient registration, treatment plans,

adverse event documentation and reporting, clinical response and long

term follow up. Trained in a variety of databases for data capture

including Oncore, INFORM, Medidata Rave etc.

. Responsible for orienting and mentoring new clinical research

associates

. Coordinate collection and shipment of PK samples according to protocol

guidelines.

. Ensured compliance with current Standard Operating Procedures, GCP/FDA

and ICH regulatory requirements

. Responsible maintaining research record (patient consent, eligibility,

case report forms, registration confirmation, corresponding source

documents, etc) and for study close outs and Archiving CRF's and

regulatory binders

. Participated in internal monitoring audits and assisted in data review

prior to publication

The monitors and study managers of various pharmaceutical companies have

appreciated my attention to detail in completing CRF and my thorough

understanding and handling of protocols. Ability to meet timelines for data

submission and query response has also been appreciated

Dept. of Biochemistry and Molecular biology, UMDNJ

Sept 2001-Jun 2004

Lab technician Dec

2003-Jun 2004

Research Assistant Sept

2001-Dec 2003

. Performed cell culture, gel shift assay (EMSA), western blot, ELISA,

protein and SDS-page gel electrophoresis, DNA plasmid purification.

Tracked order shipments, supplies and damages using Microsoft Access

and Excel

. Designed and maintained custom application for laboratory information

using Access database which maximized lab performance. Trained doctoral

students effectively on complex equipment operation and procedures.

Medical doctor

Apr

1999-Sept 2000

Life line hospital and ICCU, Mumbai: April 2000-September 2000

Ruby hospital and ICCU, Mumbai: April 1999-March 2000

. Provided care for both inpatients and outpatients in a variety of

clinical settings.

. Supervision of clinic operations and managed the clinic staff.

. Managed the ICCU

PUBLICATIONS

. IFN-( s mediate antiviral protection through distinct class II cytokine

receptor complex: Nature Immunology, Jan 2003, volume 4:69 - 77

. IL-26 Signals through a Novel Receptor Complex Composed of IL-20

Receptor 1 and IL-10 Receptor 2: Journal of Immunology, 2004 Feb 15,

volume 172/No.4: 2006-2010

POSTER PRESENTATION:

SENSITIZATION OF BREAST CANCER PATIENTS TO VINORELBINE (V) FOLLOWING

P53 INDUCTION AND MAP4 REPRESSION BY EPIRUBICIN (EPI)

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