Harsha Nalla

Clinical Research Coordinator

*** **** ***, *********, **, ad135q@r.postjobfree.com.401-***-****.

Professional Summary

Dedicated clinical research coordinator, proficient in handling patient information, laboratory samples and compliance procedures for clinical trials. Well organized and hard working with excellent communication and planning skills. Passionate and goal- oriented, having experience in clinical research, health care setting, as well as experience in biotechnology, microbiology research.

Education Certifications

Masters in biotechnology

Andhra University - Visakhapatnam, Andhra Pradesh (November 2010 to April 2012)

Bachelors in Biotechnology (2005-2009)

J.N.T.U, Andhra Pradesh, India.

Medical Assistant in RI, U.S

Lincoln Technical Institute Lincoln - Attleboro, MA (2018)

Skills

Knowledge of global safety regulations, excellent Interpersonal and communication skills both oral and written, Clinical Research, lab Research in Biotechnology and Microbiology, IRB, Electronic Medical Records, Documentation and Reporting, Regulatory Compliance, Data Management, FDA regulations, ICH-GCP guidelines, Administration, Medical terminology, Clinical skills, query management, QA, Chart Review, Detail oriented, Microsoft word, Microsoft Excel (graph creation and data and statistics analysis), Scientific paper writing skills, quick learner, ability to adapt to change, ability to follow protocol and documents, familiar with data retrieval tools, Ability to handle multiple tasks and prioritize tasks/deliverables, Ability to interpret a variety of instructions furnished in written oral, diagram, or schedule form, Regulatory submissions, thorough understanding of drug development process, case report forms, specimen handling, laboratory results management, documentation requirements, data analysis, schedule coordination, meeting coordination, enrollment coordination.

Therapeutic Area of Expertise

Phase III (Pfizer Sponsored) Lyme Disease Vaccine

Phase III (pharma-sponsored) Alzheimer and Dementia

Professional Work Experience

Clinical Research Coordinator, Pediatric Associates of Fall River. October 2022-current

-Screened study participants for inclusion and exclusion criteria.

-Recruited and interviewed study participants.

-Arranged patient visits.

-Created source documents, maintained reports.

-Collected data on research progress, adverse reactions, deviations, and results.

-Ensured regulatory compliance.

-Query solving and managing.

-Updated case reports and source documents for clinical trials.

-Document patient data on CRFs and source document at each study visit.

-Submit accurate data for e tracking.

-IRT system subject registration and randomization.

-IRB submission.

-Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, concomitant medications and lab results.

-Educated participants on studies and anticipated outcomes.

-Placed orders for medications to be used in the study.

-Took vital signs and collected medical history as a part of study protocol.

-Kept patient care protocols and clinical trial operations in compliance.

-Reviewed medical records for accuracy of source documentation prior to data lock.

-Developed source documents for data collection at the site.

-Compiled trial related documents into a master file as required by the sponsor.

-Communicated effectively with investigators, study staff, sponsors, vendors, and other stake holders throughout the trial.

-Medical chart reviewing

-Communicating and coordinating with various vendors for the smooth run of the study.

-Monitored patient safety during clinical trials according to the established guidelines.

-Developed and maintained accurate and timely databases.

-Processed and delivered specimens from study participants.

-Adhered to standards in areas involving data collection, research protocols and regulatory reporting.

-Monitored subject enrollment and tracked dropout details.

-Performed QA/QC procedures, worksheets and study materials, collected data and ordered supplies.

-Prepared sponsor files for FDA compliance and GCP guidelines

-Collected data on research progress, adverse reactions, deviations and results

Ensured regulatory compliance.

-Maintained trial policy records and procedure materials.

-Organized monitor visits.

Medicine and Long-Term Care Associates - Cranston, RI

Medical Assistant December 2020 –September 2022

● Checking vitals (temperature, weight, height, etc.)

● Patient charting and medical record retrieval

● Scheduling and rescheduling appointments as needed and required

● Data entry, Billing and Coding,

● Assisting with any clinical assessments such as EKGs

● Administering medication as per the doctors’ instructions and noted any adverse events

●office administration

● Trained to draw blood

Rhode Island Mood and Memory Institute - Providence, RI (2016-2017)

- Assisted with managing studies in phase III (pharma-sponsored) Alzheimer and Dementia

- Walked patients through the Informed Consent Form (ICF) process

- Recruited patients for Alzheimer and Dementia via doctors/physician networks and nursing home databases

- Pre-screened potential patients using inclusion and exclusion criteria for enrollment

- Data capture and entry using Redcap

- Assisted with cognitive testing when needed and required

- Working closely with the Regulatory Team in terms of IRB submissions

- Present during monitor visits to assist with any questions or concerns they may have

- Assisting the team with reporting any adverse side effects and events

College of Engineering & Technology - Andhra University, India

Senior Research Fellow (Dept of Chemical Engineering) January 2015 to December 2016

Worked on the production of L-glutaminase enzyme from actinomycetes using fermentation technique.

Production of Mevastatin using Pencillium Citrinum.

Junior Research Fellow (Dept of Chemical Engineering) January 2013 to December 2014

Worked on the production of L-glutaminase enzyme from actinomycetes using fermentation technique.

Production of Mevastatin using Pencillium Citrinum.

Research Papers

1.N. Harsha, S Subbarao, V Sridevi, MVV Chandana Lakshmi and T Kanthi Kiran (2013). Production of Mevastatin by Solid State Fermentation Using Sesame Oil Cake. Research Journal of Pharmaceutical, Biological and Chemical Sciences. Volume 4 Issue 1:P429- P436. ISSN: 0975-8585

2.N. Harsha, S Subba Rao, V Sridevi, MVV Chandana Lakshmi, T Kanthi Kiran (2013). Optimization of Physico Chemical and Nutritional Parameters for the Production of Mevastatin Using Pencillium citrinum MTCC 1256. IOSR Journal of Pharmacy. Vol. 3, Issue 1, Jan.-Feb 2013, PP.40-45. e-ISSN: 2250-3013, p-ISSN

3.N. Harsha, S Subbarao, V Sridevi, MVVChandana Lakshmi and T Kanthikiran(2013) . A Review on Mevasatin- An Anticholesterol Drug. Journal of Chemical, Biological and Physical Sciences. Vol. 3, No. 1, P384-P389. e- ISSN: 2249 –1929

4.N. Harsha; V. Sridevi, M. V. V. Chandana Lakshmi; K. Vijay Kumar (2013). Response Surface Methodology for Optimization of Production of Mevastatin by Solid State Fermentation Using Sesame Oil Cake. International Journal of Pharma and Bio Sciences (IJPBS). Volume 4, Issue 3, P392-P401.

5.N. Harsha, V. Sridevi, M.V.V. Chandana lakshmi, K.Rani, N.Divya satya vani(2013). Phytochemical Analysis of Some Selected Spices. International Journal of Innovative Research in Science, Engineering and Technology. Vol. 2, Issue 11,P6618-P6621. ISSN: 2319-8753.

6.D. Divya Teja, V. Sridevi, N. Harsha and A. Swathi.(2016). Production and optimization of l-glutaminase from mangrove isolate and comparative mutational studies. International Journal of Advanced Research (2014), Volume 2, Issue 1, 485-49. ISSN 2320-5407

7.M.P.D.Prasad, V.Sridevi, N.V.Surendra babu, O.V.S Reddy, N.Harsha.(2013).Studies on fermentative production of citric acid by Aspergillus niger isolate using sorghum malt and it's optimization. International Journal of Innovative Research in Science, Engineering and Technology Vol. 2, Issue 7, July 2013.

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