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Clinical Research Data

Location:
Smyrna, GA
Posted:
January 15, 2021

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Resume:

RAJ RAZDAN

MS Biology, MS Geology, BS Biology

**** ******* *****, *******, ** 30339

Phone: 678-***-****; Email: adjghu@r.postjobfree.com

EXECUTIVE SUMMARY: After graduating with two Masters Degrees in Sciences with specialization in Biology and Geology, Raj Razdan has 30 years experience as a researcher in the Biological Sciences conducting experiments, managing laboratories and also training students and residents in the ongoing research/studies at Emory University, Atlanta University, Kennesaw State University CDC, & Children’s Healthcare of Atlanta. She has also taught Biology and Anatomy and Physiology at Clark Atlanta University, Morris Brown and Spellman College.

SKILLS/EXPERTISE/LEADERSHIP:

Childrens Healthcare of Atlanta.

Working knowledge of state and federal regulatory guidelines related to research

JOB RESPONSIBILITIES*

Develops, conducts, and facilitates research protocols.

Supports investigators in writing study protocols and research papers

Performs participant screening, enrollment, study activities, and communication.

Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment.

Maintains equipment and supply resources for research studies.

Obtains informed consent by following policy, procedure, and regulatory requirements.

Schedules study-specific visits in conjunction with ancillary departments.

Completes data management activities.

Assists in the development and completion of source documents and case report forms.

Completes data entry and ensures data integrity.

Supports statistical services needs.

Directs patient interaction to conduct research protocols.

Administers various research surveys in accordance with research study requirements.

Completes research-only testing as required and applicable per study and system requirements, including electrocardiograms.

Provides research study education to participants as part of a study protocol.

Completes documentation as needed within the medical record.

Monitors compliance throughout all study activities and engages compliance oversight as needed.

Participates in education activities to support specific research activities and primary role at Children’s Healthcare of Atlanta.

Maintains all licensure, certification, and system education requirements for role.

Participates in educational activities related to study needs for study staff, investigator team, and patient care staff.

Participates in departmental policy and quality projects.

Manages all regulatory processes related to clinical research activities.

Completes Institutional Review Board preparation, submission, modifications, reporting, and termination activities.

Maintains all regulatory documents.

Participates in sponsor correspondence, monitoring, and study meetings.

Supports Principal Investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.

SYSTEM RESPONSIBILITIES*

Safety: Practices proper safety techniques in accordance with hospital and departmental policies and procedures. Responsible for the reporting of employee/patient/visitor injuries or accidents, or other safety issues to the supervisor and in the occurrence notification system. Compliance: Monitors and ensures compliance with all regulatory requirements, organizational standards, and policies and procedures related to area of responsibility. Identifies potential risk areas within area of responsibility and supports problem resolution process. Maintains records of compliance activities and reports compliance activities to the Compliance Office.

Clinical Research Coordinator 11

Emory University

Screens patients.

Determines eligibility for enrollment in studies, schedules procedures, creates and maintains research records, Coordinates services, and enters charges for patients in the web based clinical research financial management database.

Manage research project databases, develops flow sheets and other study documents and completes source documents and case report forms. Work on different databases, such as Medidata Rave, Redcap, PPD, Suvoda, Bracket, Bioclinical,AGMedNet, LIMS, Inform, Open specimens, and PIMS. Inform enter data and do data analysis. Answer Queries.

Updates Research data on Oncore specific to different clinical trials. Maintains and organizes research records for different clinical studies.

Monitors scheduling of procedures and coordinates other services as needed.

Assists in recruiting and screenings for study participants including interviews and questionnaires as per protocol requirements.

Schedules and orders labs tests, scans EKG, eye exams and procedures for the clinical trial patients. Communicating with patients to ensure that they are informed of current and futures schedules and treatment arrangements.

Communicate with the regulatory team of all the AE’s SAE’s deviations or violations. Ensure compliance with research protocols in the collection of study specimens and processing.

Review case reports forms and audits for accuracy with source documents. Ensure that monitors are scheduled for appropriate meetings and visits with the clinical trial teams.

Attends monitoring meetings with monitors asking questions and communicating with the monitors related to data.

Provide monitors essential documents and access to patient files records and information necessary to conduct the visit.

Tittle:Senior Technologist and Research and Development Coordinator/ Lab director. Manager

Employer : Onpoint laboratory

January 2014-Feb 2017

The overall scope of work includes managing the laboratory as well as performing experiments on current research projects. This project involves working with competitive enzyme immunoassays for the quantitative analysis of 8 mycotoxins in Urine. The test is based on the antigen –antibody reaction. Current research involves mass spectroscopy for detection of mycotoxins in human urine.

My responsibilities include:

Operating analytical instrumentation the Shimadzu LC-MS/MS instrument..

Executed the sample preparation techniques for LC-MS/MS analysis and running samples on the LC-MS/MS

Organized the reference materials, specimens and data collection.

Maintained detailed records of the chain of custody to the final recipients including mediating any shipping disputes

Coordinate of research projects and laboratory personnel, data management and adherence to fiscal expenditures.

Supervised maintenance of equipment and supplies

Managed laboratory functions including ordering the necessary chemicals, equipment, and other consumables as well as other supplies for the Mycotxins Project.

Worked on writing the SOP for the Mycotoxins

Organized the inventory and maintained detailed records about patient samples for the study.

Mentored and trained laboratory personnel on equipment and instrumentation

Assisted in moving the Mycotoxin Project towards IRB and CLIA compliance

Perform pipette calibration verification every 6 months for the Mycotoxin Project.

Responsible for maintaining the Chemical Hygiene and Control Plan

Responsible for the ticketing and disposal of chemical waste.

Also involved with

1. 1. Validation /verification of mycotoxins EIA tests

2. 2. R & D manager

3. 3. Planning for patient testing

4. 4. Testing using EIA for Mycotoxins

5. 5. Developed EIA Testing protocols

6. 6. lAL tests for Endotoxins. The PTS reader tests for Endotoxin and Glucans based on Chapter 85 from USP. Testing was performed on human urine for endotoxins and Glucans.

Attend team meetings and communicate with the different teams and various doctors. Orders and maintains supplies, kits and equipment per protocol.

Research (Molecular Biology, Biology, Microbiology Immunology and Virology Toxicology): RNA extraction and purification Protein isolation, purification and expression using various biochemical techniques from tissues and cells, purification and protein concentration and determination, Regenerated columns, Preparation of membrane proteins, DNA sequencing Agarose gel electrophoresis, Quick change Site–Directed mutagenesis System (QCM) allowing efficient mutagenesis without sub cloning Plasmid DNA preparation and purification DNA restriction digestion and plasmid DNA insertion DNA transformation of competent cells DNA, Preparation and Storage of bacterial stocks Native and SDS-PAGE, Southern, Northern, and Western transfer techniques RT-PCR Plasmid DNA transfection of eukaryotic cells Antibody purification cell culture techniques including propagation, maintenance, and bioassays, e.g. cell proliferations assays Chemiluminescence’s techniques and assays, Preparation and testing of bacterial lipopolysaccharides ELISA assay development and techniques, Phlebotomy Genotyping, Allergic reactions assays Mouse handling, dissection, serum collection, Histochemistry and immunohistochemistry Virus propagation, titration and plaque assay techniques . Mycotoxin Extraction and purification

Instrumentation/Equipment expertise:

HPLC, GC, Spectrophotometer, PCR, TaqMan, Liquid scintillation and gamma counters, ELISA, UV-VIS spectrophotometer pH meter, drying oven, Karl Fisher titrators

Microscopy, Column chromatography, Biological safety cabinets (aseptic techniques)

Trained in several analytical procedures involving RIA, cell fractionation, electrophoresis, gel filtration of macromolecules, microbiological procedures, and Fuorometer, Luminometer, Immunoassay analyzers (Abbott AxSym), LC/MS/MS (Gilson) and Shimadzu

Teaching:

Taught college level courses and laboratories in Biology, Anatomy and Physiology at Clark College (Atlanta University), Morris Brown, Spelman College, Dekalb Community College and Gwinnett College

Management/Administration:

Coordinate activities of research projects and laboratory personnel, which include analytical R&D, QC and operations to ensure timely development and transfer of projects in process.

Supervise data management and adherence to fiscal expenditures and experience with laboratory Information management.

Supervise maintenance of equipment and supplies

Train laboratory personnel on equipment and instrumentation along with lab safety requirements and best practices

Supervise laboratory safety and maintained safety protocols

Supervise usage and safe disposal of radioactive and hazardous material

Supervise work-study students and Residents

Serve as liaison between the principal investigator and the technical staff

Helped with the writing of the grant proposals. Good written and oral communication skills along with problem solving and decision making skills Ability to be a team player and work well in a team environment. Ability to provide work direction to team members.High level of initiative and self motivation.

Responsible for laboratory equipment, chemical and reagent purchases

Proficient with computer software including MS-office programs Photoshop as well as other types of software for data analysis.

Maintain current data files both hard copy and electronic on specimens, supplies.

Assists in the management of research project databases (including Lab Inventory Management System, REDCap, 0ncore, Rave, Inform, open specimens

PIMS,etc.)

Adhere to strict confidentiality as it relates to all data. Adhere to the Universal Precautions/CLIA/ISO guidelines with regard to the handling of biological samples and biological waste, laboratory protocols and quality control.

EDUCATION:

MS Atlanta University (Biology)

M.Sc Poona University, India (Geology)

B.Sc Poona University, India (Botany; Zoology, Geology, Physics, Chemistry)

PROFESSIONAL EXPERIENCE:

Jan 2019-August 2020

Job Title: Clinical Research Coordinator

Employer: Children’s Healthcare of Atlanta

May 2017- June 2018

Job Title: Clinical Research Coordinator II

Employer Emory University

Jan 2014- Feb 2017

Job Title: Senior Technologist and Research and Development Coordinator/ Lab director. Employer: On point laboratory

May 2009 - Feb 2013; Job Title: Research Professional AD III Employer Kennesaw State University

Nov 2006 - Feb 2009; Job Title: Chemist Employer: Centers for Disease Control and Prevention (CDC Foundation);

Oct 2003 - Dec 2004; Job Title: Senior Laboratory Technician Employer: Centers for Disease Control and Prevention (CDC) AREF;

Nov 1980-2003 and 2004 - Aug 2006; Job Title: Research Specialist Sr.

Employer: Emory University, Dept of Medicine

PUBLICATIONS/PRESENTATIONS (in chronological order):

1. Trans. SE Pharmacol. Soc. 2:29, 1981. Effect of long-term treatment with hydralazine on systolic blood pressure of spontaneously hypertensive rats Z. H. Israeli, R. Razdan and F. Walters.

2. Trans. SE Pharmacol. Soc. 3:32, 1982. The influence of retinoid administration on the type of skin cancer induced by UV light in hairless mice. Z.H. Israeli, V. Nassar and R. Razdan. 3. Pros. Amer. Assoc. Cancer Res. And ASCO 23:204, 1982. Effect of vitamin A and analogs on the induction of squamous cell carcinoma in hairless mice caused by solar simulated UV-light. Nassar. Z. H. Israeli, R. Razdan and I. Willis. 4. Fed. Proc. 41:1673, 1982. Effect of age, alcohol and type of diet on the induction of UV-light induced skin cancer in hairless mice. Z. H. Israeli, R. Razdan and V. Nassar. 5. Proc. Soc. Exp. Biol. Med. (Abstract). The influence of dietary fat on UV-carcinogenesis in hairless mice. Z. H. Israeli, R. Razdan and V. Nassar. 6. Amer Acad. Of Allergy and Immunol. 1985. Albumins enhance histamine release from human basophils. T. F. Smith and R. Razdan 7. (Abstract) Emory University School of Medicine, 2003. Long Term functional survival o Microencapsulated allogenic B- Cell lines in spontaneously diabetic Nod mice. Safley, S.A Kapp, L.M Burden, C.Y., Razdan, R., Constantinidis, I., and Weber, C.J. 8. Monoclonal Antibodies to SARS-Associated Coronavirus (SARS-CoV):

Identification of Neutralizing and Antibodies Reactive to S, N, M. and E Viral Proteins. Ralph A. Tripp, Lia M. Haynes, Deborah Moore, Barbara Anderson, Azaibi Tamin, Brian H. Harcourt, Les P. Jones *, Mamadi Yilla, Gregory J. Babcock, Thomas Greenough, Donna M. Ambrosino, Rene Alvarez, Justin Callaway, Sheana Cavitt, Kurt Kamrud, Harold Alterson, Jonathan Smith, Jennifer L. Harcourt, Congrong Miao, Raj Razdan, Andy Comer, Pierre E. [CDC] 9. Presented at the APHA Annual meeting in Washington DC on Nov. 8, 2004. Senior Citizen Programs and strategies as a model for improving South Asian elderly well being. Raj Razdan. 10. The endocrine society’s annual Meeting, ENDO 2008, Poster; San Francisco, CA Assessment of specimen Preparation Procedures for Testosterone Measurements by Isotope-Dilution Liquid chromatography-tandem mass Spectrometry. Julianne Cook Bothelo, Christopher Shacklady, Raj Razdan, Hubert Vesper [CDC] 11. American association for Clinical Chemistry annual conference 2008, Poster. Impact of sample preparation procedures for Testosterone Measurements by Isotope-Dilution Liquid Chromatography-Tandem Mass Spectrometry. Julianne Cook Bothelo, Christopher Shacklady, Raj Razdan, Hubert Vesper, Washington D.C. July 27-31. [CDC]

12. LSAP Conference, Athens GA Oct 4-6 2012 Poster Fluorescence detection of obligatory conformations in catalysis and control of NOS Vladimir S Moricette, Chioma G Enweani, Ezigbobiara N Umejiego, Army Lester, Raj Razdan, Carol A. Christensen, Jonathan L. McMurry & John C Salerno, Kennesaw State University, Kennesaw, GA.

13. Biosci.Rep290

14)Endothelial nitric oxide synthase is regulated by ERK phosphorylation at Ser 602.

John Salerno, Dipak Ghosh, Raj Razdan, Katy Helms, Christopher C. Brown, Jonathan McMurry, Emily A Rye and Carol Christensen.

Dept of Biology Kennesaw State University.

14. AAN abstract 2020

Anti-Adeno-Associated virus (AAV) neutralizing antibody (Nab) titers in Duchenne muscular dystrophy (DMD).

Sumit Verma, MD, Raj Razdan, MS, Saila R. Upadhyayula, MD, Han C. Phan, MD, David Lee BS, Thomas H. Vanderford, PhD.

REFERENCES: Shall be provided upon request.

Dr Sumit Verma Children’s Healthcare of Atlanta

Dr Susan Safley Emory University

Dr M Miller On point laboratory

Dr Dipak Ghosh Kennesaw State University

Dr Army Lester Kennesaw State University



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