Resume

Sign in

Data Clinical Research

Location:
Woodbridge Township, New Jersey, United States
Posted:
October 11, 2016

Contact this candidate

Resume:

Persis S. Bandari

(Certified (CRC) Clinical Research Coordinator)

(Available for Immediate Assignment)

SUMMARY:

PhD and 10+ Years’ experience in Clinical Research

Maintained regulatory documents-FDA and IRB approvals

Provided timely and professional ongoing quality management of clinical trial data through by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared cleanup

Worked with EDC management systems including: J-Review, Oracle Clinical, RAVE, MedDRA and REDCAP

Assured integrity of clinical data with respect to accuracy, accountability and documentation through review of CRFs source documents and medical records

Coordinated logistics and analyzed data for study that evaluated residential patterns of Cardiac Patients with cardiac problems and massive heart attacks

TECHNICAL SKILLS:

EDR

MedDRA

Electronic Data Capture Software

Cerner, Patient tracking

Oracle Remote Data Capture

Schedule Maximize

Oracle Clinical

ONCORE

Web builder

Infoed,Citrix, invision

QDR

Rave

J-Review

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Access

EDUCATION:

Ph.D, Marathawada University - India (WES Equivalency: US earned Doctorate)

Masters, Zoology Marathawada University - India

Bachelors (BS) - Biology -- Kakatiya University - Warangal, India

CERTIFICATION/ TRAINING:

Certified (CRC) Clinical Research Coordinator - BRANY, NY-2006

Quality Data Services, as Study Coordinator - QDR, -2010

(Electronic Data Capture System)

HIPPA -Privacy and Security-2010

Corporate Compliance (Code of Conduct)-2009

Data Security in Human Subject Research Training session -2007

Human Participant Protection Education Research Teams-Sponsored by NIH-2007

HIPPA Training Session-2007

WORKED IN CLINICAL PROJECTS:-

CTEP- Cancer therapy Evaluation Program

CIRB-Central Institutional Review Board

REDCAP-Research Data Capture

IRBNET-Institutional Review Board

CITI - Collaborative institutional training institute

ECOG- Eastern Cooperative Oncology Group

SWOG- Southwest Oncology Group

NSABP- National Surgical Adjuvant Breast and Bowel Project

CALGB- The Cancer and Leukemia Group B

Therapeutic

Areas: - Oncological studies

Field of gynecologic malignancies (ovarian cancer, uteri cancer, Cervical cancer)

2.GI STUDIES .(Hepatic cancer, bowel cancer, stomach cancer )

EXPERIENCE:

Sollers Education - Faculty 03/2015- Present (part-time)

Educating & training various clinical researchers Real experiences in clinical trials between institution and pharmacy

Clinical Research Academy of America (CRAA) – Edison 1/2014-03/2015(Part-time)

Subject Expert –Clinical Research / Faculty (Part Time)

Training young clinical researchers on following:

CDM-& CRA Courses

Clinical Data Acquisition

Training, Education, and Documentation Requirements

Clinical Data Management Process including RAVE & J-Review

Forms Management

Patient Registration

Data Entry Methods & Processes

Atlantic Health System, Overlook Medical Center - Summit 4/2013-5/2013

Regulatory Compliance Coordinator/Data Manager

Maintained accurate patient files and records for each clinical trial.

Maintained regulatory documents-FDA and IRB approvals

Processed new protocols including preparation and timely submission to the IRB following both institutional and federal guidelines.

Responsible for protocol database with submission and approval information.

Developed, maintained and distributed the regulatory binder.

Maintained active protocols lists per institution and distributed to all participating medical staff

Communication with the appropriate clinical staff regarding submissions and approvals.

Processed annual reviews and updates.

Processed protocol status changes and ensured timely submission to the IRB and communication with clinical staff

Maintained all regulatory files for closed protocols and their related case report forms for on-site or off -site storage

Maintained active and follow up database on all patients enrolled on clinical trials.

NYU Cancer Institute - New York, NY 10/2008-12/2011

Clinical Data Manager; Phase I, II, III & IV

Processed Oncology clinical data including receipt, entry, verification, or filing of information.

Performed quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.

Provided support for CRAs with training on study protocol, eCRF completion guidelines.

Conferred with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols.

Provided timely and professional ongoing quality management of clinical trial data through by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared cleanup.

Worked with EDC management systems including: J-Review, Oracle Clinical, RAVE, MedDRA and REDCAP

Cleared CRF's backed up queries, resolved all discrepancies in timeline fashion.

Performed site management, investigative site file reconciliation, source document verification, drug accountability and document deviations to protocol.

Performed health economics and outcomes research for Clinical Trials.

Assisted with protocol development, design and review; verification and validation of medication safety; recruitment of study participants; administration of informed consents; sample and study document preparation; and data collection, interpretation and analysis.

Provided accurate statistical analysis of clinical data utilizing SAS and prepared thorough reports in accordance with internal guidelines and federal regulations.

Monitored work productivity or quality to ensure compliance with standard operating procedures.

Processed safety reports, etc.

Data cleaning via patient profiles and listings. Ensure all visits and pages are in and provide status of reconciliation

Data Coordination & Oversee all aspects of trial (SIV, Lab, Pathology, Radiology, Pharmacy working with Physicians,Research Nurses, in oncology involved in various clinical trials Co-coordinators and NYU staff members.

Manage clinical trial coordination activities (DSMC:-Data safety Monitoring committee) expertise.

Provide input into the development and review of all clinical study reports and documentation, including but not limited to; study protocol, progress reports, clinical study reports, applicable documents required.

Monitors clinical studies as per ICH/GCP guidelines and applicable SOPs.

Ensures the completion of all applicable SOP and study related documentation maintained within aTrial Master File (TMF) for all clinical trials which files the essential trial documents.

Ensures the timely, accurate and complete collection of all study data.

Develops and maintains applicable site and monitoring working documentation, i.e. monitoring plan, source documentation template, etc.

Review and approved applicable monitoring reports, provide feedback as applicable

Overall responsibility for all clinical trial related documentation

Ensure completion of all data of clinical trial so that it can be entered in clinical applications

Ensure timely reporting of all Adverse Events (AE’s)

SAE reconciliation, etc.

Case Report Form completion

Maintain patient study file

Ensure patients are followed for survival when required by protocol

Worked as data Manager to Research point pharmaceutical company through NYU for their clinical study for GOG-023c trial

1.Interim monitoring visit

2.Reviewed CRF’s and source documents.

3.Reviewed all protocol deviations and violations

4.Reviewed drug storage and inventory

5.Reviewed patients documents for Serious Adverse Events

Data capturing all patients Scheduled and follow up with all patients screened or enrolled into studies

Host all monitoring visits and complete any follow up generated by the pharmaceutical monitors

Worked on

Excelled in managing high-priority projects and resolving data discrepancies, errors and omissions with thoroughness and expedience.

The American College of Surgeons Oncology Group (ACOSOG) Mayo Clinic CC Remote Data Capture - Data will be collected using the MCCC Remote Data Capture (RDC) System.

Remote Data Capture (RDC) System.

QDR - Quality Data Reporting( Quality data services )

CTSUOC- (Clinical trials support unit- a service of the National Cancer Institute)

Electronic Data Capture & Clinical Applications:

Oracle Clinical (OC) Citrix, invision & Onbase ( Medical charts review online) EDR(Electronic Data Repository) Input of queries into OC-RDC database

Infoed ( Clinical trials study information updates) oracle Clinical, Ctrix, schedule maximizer,MedDRA,Identify different trials of patients who discontinues (biweekly)

SCC (single sign on)

Cerner, Patient tracking,

TDS (patient medications)

Microsoft word documents

Spread Sheets

GOG-CRF’s (SEDES - SDC Electronic Data Entry System)

Clinical Data Acquisition Standards Harmonization (CDASH)

Adeers (Adverse Event Expedited Reporting System (AdEERS)NCI's web-based system for submitting expedited reports for serious adverse events and/or unexpected Adverse events forwarded to designated recipients and the NCI for all trials using a NCI-sponsored investigational agent. only registered Data managers can entitled to enter data on this site

AE'S /SAE ARE reporting system to Institutional IRB office, sponsors and principal investigators timely by web system/facsimile.

Mount Sinai Medical Center, 11/2004-7/2008

Cardiovascular Institute - New York, NY

CRC-; Phase I, II & III

Responsible for patient recruitment and enrollment in cardiac drug trials (FREEDOM, SKS,PRECISE.PREDICT)

Performed health economics and outcomes research for pre-launch phase of new products

Performed documentation of patient information before and after catheterization procedure

Maintained patient information in relation to medication risks and complications

Assured integrity of clinical data with respect to accuracy, accountability and documentation through review of CRFs source documents and medical records.

Coordinated logistics and analyzed data for study that evaluated residential patterns of Cardiac Patients with cardiac problems and massive heart attacks.

Responsible for data management, statistical analysis and result publications.

Participated in data collection and management.

Prepared documentation, Electronic data repository.

Maintained research SOP’s and GCP’s

Successfully planned and implemented research studies from start to finish.

UMDNJ - Newark, NJ 1/1998-1/2004

Research Teaching Specialist/Research Associate/Post Doc Fellow

Prepared, manipulated, and managed extensive databases.

Verified the accuracy and validity of data entered in databases, correcting any errors.

Performed descriptive and multivariate statistical analyses of data, using computer software.

Provided assistance with the preparation of project-related reports, manuscripts, and presentations.

Obtained informed consent of research subjects or their guardians.

Prepared tables, graphs, fact sheets, and written reports summarizing research results.

Edited and submit protocols and other required research documentation.

Developed and implement research quality control procedures.

Presented research findings to groups of people.

Worked as internal member for project on trauma patients and how multiple organs of patients acquire sepsis in trauma cases and analyzed molecular and electrophorectical studies of tissues

2000-2003: Held Team leadership position in cloning of novel gene(HGFIN)

Worked on biochemical assays to find signaling pathway studies of different receptors in brain & how they signal target organs and produce a response.

PUBLISHED ARTICLES (13)

18 PUBLICATIONS /PRESENTATIONS/20 abstracts submitted in reputed international scientific journals.



Contact this candidate