CRA

Rohit Kalra

****, ******* ****, *** **. **, Downers Grove, IL-60515, USA

Phone: 321-***-**** • Email: **********@*****.***

OBJECTIVE

Seeking a position to utilize my skills and abilities in the industry that offers professional growth while being resourceful, innovative and flexible.

SUMMARY

•Excellent understanding of GCPs, ICH guidelines, FDA regulations, and applicable SOPs

•Two years clinical research experience in monitoring various therapeutic areas like, Neurology, Gastroenterology, Endocrinology, Medical Device, Oncology, Pulmonary/Respiratory Diseases, and Rheumatology.

•Three years of clinical research coordination experience.

•Participates in the development of study specific site coordinator and pharmacy training materials. Review regulatory documents, investigational product accountability, Case Report Form, source document verification and prepare site visit reports.

•Reviews clinical data, reports, and identifies issues and trends. Reviews monitoring visit reports and ensures adherence to study protocol and timeliness. Take corrective action to resolves issues or unfavorable trends.

•Generates and utilizes metric tools to assure study is running per timelines and budgets as well as alerting up-line management to potential issues.

•Provides guidance and instructions as needed to site coordinators. Researches and responds to routine, non-routine, and complex inquiries in a timely and professional manner.

•Strong working knowledge of guidelines, and systems for clinical trial management

•Excellent interpersonal, verbal, and written communication skills

•Participates in investigator meetings. Site selection, initiation, interim and closeout monitoring.

EDUCATION

2004 – 2006 Master in Biotechnology

Florida Institute of Technology, Melbourne, Florida

1997 – 2001 Bachelor in Pharmacy

Hamdard University, New Delhi, India

SKILLS

Instruments:Expert in handling circular dichroism spectroscopy, flow cytometry, atomic force microscope, confocal microscope, electron microscope, fluorescent microscope, luminometer, HPLC, cryostat.

Laboratory Skills: Cytochemistry and Immunohistochemistry, DNA extraction and DNA Electrophoresis, Transformation, RNA extraction and hybridization, Standard PCR, Real-time PCR, Western blotting, Northern blotting, Gel Electrophoresis, mammalian Cell culture, Luciferase assay, protein assays, ATP and calcium quantification.

COMPUTER PROFICIENCY

Systems Windows NT/2000, Macintosh

Languages SQL

Databases Oracle, MS Access

Applications MS Project, MS Visio, Use Case Diagrams, MS Office.

PROFESSIONAL EXPERIENCE

2010 – Present Clinical Research Coordinator

Avicenna DM Clinical Research, Chicago, IL

Job Responsibilities

•Initial Study start-up activities

•Conducting study visits with patients

•Managing charts and patient data

•Maintain required records of study activity including case report forms, research files, adverse event reporting, database records, and thorough source documentation as required by audit regulation.

•Dispensing and managing study medications

•Serving as a liaison between physician and study team

•Study close-out activities and reports

2008 – 2010 Clinical Research Coordinator

Apex Clinical Trials, LLC, Birmingham, AL

Job Responsibilities:

•Oversee the conduct of assigned clinical studies including acting as liaison to clinical investigators, ensuring the quality and integrity of data.

•Prepare and conduct study initiation, closeout and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols and project plans in accordance with FDA regulations.

•Maintain site files, trial master files and study documentation.

•Develop status reports, CRFs, SOP revisions and document quality control.

•Review and process regulatory documentation, ensure the execution of clinical trials in a timely, efficient manner, working within established timelines and budgets.

•Track clinical trial supplies, patient recruitment activities, and Serious Adverse Events, review Case Report Forms for accuracy and completeness and conduct query resolution.

•Identify investigator sites for participation in trials.

•Monitor the execution of the clinical study against the specified timelines, deliverables, budget, and expense analysis.

•Assist PI with research subject recruitment, screening, enrollment, informed consent process, sample collection (phlebotomy) and sample processing.

2007 – 2008 Research Assistant (Internship)

Florida Space Research Institute, Kennedy Space Center, FL

I did my industrial internship under the supervision of Dr. Shaohua Xu at SLS Lab to understand the role of lipoprotein in bone formation and bone loss which is one of the main concerns for Astronauts who lose 1-2% of their bone minerals per month during space flights.

Job Responsibilities:

•Structural analysis of Bone/collagen by using Atomic Force microscope (AFM) and Transmission electron microscope (TEM).

•Conduct research on animal model system, to understand the role of lipoprotein in bone formation.

•Use various molecular techniques like immunostaining and western blotting to localize putative lipoprotein which involve bone formation.

•Worked as a research assistant for instrumentation lab, training and supervised work study students

•Responsibilities included maintaining supplies and lab equipment (AFM, SEM, Confocal, fluorescent microscope, circular dichroism, Flow Cytometer)

•Attended training sessions from Carl Zeiss and Nikon instruments for microscope and software management.

2005 – 2006 Research Assistant

Florida Institute of Technology, Florida

I worked under the guidance of Dr. Alan Leonard (FIT) as a research assistant to understand the complex molecular machinery that regulates cell growth of E coli bacteria. I did my research on the evaluation of mutant (G to T) version of E coli chromosome replication origin with reduced requirement for initiator protein (DnaA), in order to determine the role of I - sites in the bacterial cell cycle regulation.

Job Responsibilities:

•Responsibilities include maintaining lab protocols, editing manuscripts, maintain and ordered lab supplies and instruments.

•Use various molecular techniques like mutational experiments, immunostaining, western blotting, DNA foot-printing, flow-cytometry to determine the DnaA requirement for I-sites during E coli chromosome replication.

•Trained work-study students for various lab protocols like gel electrophoresis, immunostaining, western blotting, northern blotting, and flow-cytometry etc.

2004 Teaching Assistant - Biochemistry Lab

Florida Institute of Technology, Florida

Job Responsibilities:

•Worked as a teaching assistant with Dr. Russell Weigel for biochemistry Lab.

•Responsibility includes teaching lab session, grading and managing coursework for 30 students.

2002 – 2004 Clinical Research Associate

Siro India – Contract Research Organization (CRO)

Job responsibilities:

•Conduct of pre-trial, initiation, monitoring and closeout visits at study sites

•Ensure quality of data submitted from study sites and assure timely submission of

data, including appropriate reporting and follow-up for all safety events by site personnel.

•Report monitoring activities and study site conduct accurately and completely.

Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.

•Assisted investigator in recruiting subjects according to the protocol and further reviewed

the patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.

•Assist the Project Manager with monitoring drug supply to ensure adequate

availability throughout trial and coordinate re-supply with the Project Manager and external vendors, as appropriate.

•Prepared the site to conduct study, trained the involved people, set up and organize study files, created and reviewed study related source documents (medical records, CRF. •Assisted project teams by ensuring that all data is collected and submitted with in appropriate time lines and communicates these time lines to the investigational sites.

2001 – 2002 QA Analyst (Microbiologist)

SRL Ranbaxy pharmaceuticals (India)

Job Responsibilities:

•Diagnosis & reporting of Clinical/research specimens.

•Performed antibiotic sensitivity tests and drafted associated reports.

•Conducted sterility and quality control activities for laboratory equipment, solutions and drugs.

•Supervised culture media preparation and lab reagents.

•Maintained microbial cultures and patient clinical records.

HONORS AND AFFILIATIONS

IATA Certification

Member of ACRP

Member of the American Society for Microbiology

Member of American Microscopical Society

RELOCATION

No Preference

REFERENCES

Will be furnished upon request.

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