CRA

Shailaja Lakma

Completed MS in Biotechnology and has certifications in Science of Clinical Trials and Design ,Drug Safety and Adverse Events Reporting, Clinical Site Monitoring and Global conduct of Clinical Trials. Have extensive years of experience as a Clinical Trial Assistant complied with all company safety regulations and FDA regulations.Have strong knowledge of GLP and ICH guidelines. Maintained Trail Master file including all essential documents. Actively participated in clinical excellence program through Sanofi Aventis for better understanding of ICH GCP guidelines, in review of Clinical Research documents (e.g. Protocols, CRFs) and in team meetings and weekly meetings with the CRO.Has extensive experience in maintaining Investigator’s brochures, Protocol/ study procedure manuals, in reviewing eCRFs and providing input on eCRFdesign.Collection of data by EDC

Summary:

• More than 3 years of experience as a Clinical Trial Assistant.

• Complied with all company safety regulations and FDA regulations

• Has knowledge of GLP and ICH guidelines

• Participated in clinical excellence program through Sanofi Aventis for better understanding of ICH GCP guidelines

• Proficient in MS Office Suite

• Strong written and oral communication skills

• Have good attention to detail and organizational skills

• Very good time management, and able to meet deadlines

• Enthusiastic team player and able to work independently

• Collaborate in team and produce quality reports

Education/ Certification:

• MS in Biotechnology, Bangalore University, Bangalore, India, 2006

• BS in Microbiology & Genetics, Osmania University, Hyderabad, India, 2009

• Science of Clinical Trials and Design – UC, Santa Cruz ( Aug- 2010)

• Drug Safety and Adverse Events Reporting – UC, Santa Cruz ( Aug- 2010)

• Clinical Site Monitoring I – UC, Santa Cruz ( May - 2011)

• Global Conduct of Clinical Trials (Oct- 2011)

Johnson & Johnson, South San Francisco, CA

Clinical Trial Specialist

(Project: Phase II and Phase III studies (Summit AD, RAPID and INROADS) Nov 11- Present

• Building Trial Master file according to the company’s filing structure

• Getting SRPs ready to be sent to the sites

• Getting studies registered on www.clinicaltrials.gov

• Coordinating with the CROs about the study progress

• Taking down meeting minutes for the studies

• Collection of data by RAVE EDC system

• Filing Case Report Forms

• Updating the randamizaton tracker

• Coordinating with Vendors about the weekly reports

• Organizing and maintainance of PSSV and SIV reports

• Obtaining necessary study approvals

• Submission of essential documents (Level I,II and III) to the Trial Master File

Abbott Vascular, Menlo Park, CA Jul 10 – Oct 11

Clinical Research Assistant

(Project: MitraClip System ANZ Clinical Trial, ACCESS-EU Clinical Trial, MitraClip HF Clinical Trial)

• Filing case report forms and organizing data related to study

• Responsible for data analysis and protocol editing

• Participating in review of Clinical Research documents (e.g. Protocols, CRFs)

• Participating in team meetings and weekly meetings with the CRO

• Maintenance of regulatory binders and study site binders

• Maintenance of Trail Master file including all essential documents

• Coordinating team meetings and taking down meeting minutes periodically

• Maintaining the content of the Investigator’s Brochure and sending updates to the sites when required

• Maintaining AE logs, SAE logs, Screening log, follow-up logs etc using MS Excel and following up with site coordinators to ensure accurate reporting of clinical study Adverse Events

• Coding for Adverse Events using the company’s standard codes

• Collection of data by EDC and Clinical Data Fax systems

• Reviewing eCRFs and proving input on eCRF design

• Tracking subject recruitment metrics

• Assisting in the determination of clinical supply requirements

• Linking export data with the commercial data for further analysis using Excel and MS Access

Alpha Analyticals, Dublin, CA. Mar 09 – Apr 10

Microbiologist

• Strong analytical skills and hands-on experience with HPLC ,CE, SDS-PAGE and PCR

• Worked with bacteria E.coli, Pseudomonas, and Klebsiella

• Total and Fecal Coliform analysis of Drinking water and waste water

• Coliform analysis using colisure, colilert and MPN methods

• Calibration of electrical instruments in the lab

• Bottle order fulfillment required by the client

• Preparation of standards, controls, stocks and cultures according to the protocols

• All general Microbiological procedures performed under GLP regulations

• Chemical analysis using electrical and optical instruments

• Reagent preparation on a regular basis

• Data entry through LIMS software

• Client interaction regarding sample issues and tracking of samples received from various clients

• Maintain adequate samples and other requirements in the Lab and ordering required equipment and chemicals for the lab.

Sanofi Aventis, Hyderabad, India Dec 06 – Aug 08

Clinical Research Coordinator

(Project: An international, multi-center, randomized, double-blind, parallel group, study of 3-month or 6-month treatment with symptomatic pulmonary embolism, with or without symptomatic deep vein thrombosis.)

• Filing case report forms and organizing data related to study

• Inform ethics committee about adverse events and amendments

• Handling equipment related to study

• Obtaining informed consent from patients participating in studies

• Maintaining Investigator’s brochures, Protocol/ study procedure manuals

• Monitoring Reports/Case study forms

• Deliver samples to appropriate assay groups and archive additional samples returned from the assay group

• Assisting in the determination of clinical supply requirements

• Source documentation Verification at the site

BioMinds, Hyderabad, India Jul 03 – Jul 05

Research Assistant

• Isolation of E.coli from various samples

• Estimation of amount of Protein, DNA and RNA in various samples

• Detection of presence of antigen or antibody in the sample using ELISA

• Quality check control using ELISA

• Detection of specific Proteins using Western blotting techniques

• Separation of proteins according to their electrophoretic mobility using SDS-PAGE

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