Nadeeka Randunu

adg0jt@r.postjobfree.com

240-***-****

CLEARANCE: NACI-Public Trust Level 5b

CAREER HIGHLIGHTS

Clinical trial that I supported/coordinated wins the David Sackett Trial of the Year Award for 2019

5 years of program experience in the United States and West Africa in the research field (cold chain/ procurement/ order management/contracts/sub-contracts).

Assisted in the Ebola Treatment Units (ETUs) in Liberia as a response team member for the West African Ebola Outbreak

Managed and trained 13 laboratory technicians and laboratory assistants to handle potentially highly hazardous specimens like Ebola, HIV and syphilis (BSL 2-3) according to GCP and GLP guidelines

PROFESSIONAL EXPERIENCE

Response Support Scientist

NATIONAL INTERAGENCY BIODEFENSE CAMPUS

Battelle/Laulima, Integrated Research Facility (NIAID), Fort Detrick, MD

2019-Current

Principal data manager and organizing CRFs. Analyze and manages data for many different projects in different countries. Tracks data progress creates reports and reports to PIs.

Biosafety Level 4 (BSL-4) trained. Enrolled in the NIH Division of Occupational Health and Safety, Biosurety and Select Agent program. Trained and cleared to handle select agents.

Supports outbreak activities (Training management, technical, logistical, capacity building, procurement and order management) in DRC, Mali, Liberia and Guinea.

Project lead for PROPEL study in Liberia, PALM study in DRC, equipment troubleshooting and Mali research lab operation and procurements.

Performs FANG (Filovirus Animal Non-Clinical Group) ELISA on serum samples

Responsible for training staff on analytical techniques, basic laboratory procedures and troubleshooting equipment. Mentor local Liberian staff on research topics and procedures.

Coordinating the team’s involvement in a malaria surveillance study in Liberia (PROPEL).

Ongoing COvid-19 plasma study

Design and develop SOPs.

Collaborate with Cepheid, INRB and CDC to develop an Xpert Hemorrhagic Fever Test for detection of pan-Ebola, Marburg, Crimean-Congo Hemorrhagic Fever and Lassa.

Research Associate II

Leidos Biomedical Research, Inc., Clinical Monitoring Research Program Frederick, MD (NIAID) 2015-2019

Assisting with initiation, sub-contract personal management and conduct of:

o5-year observational cohort study of Ebola survivors and close contacts in Liberia (NIH)

oPhase I/II Ebola treatment studies (Gilead Sciences, Mapp Biopharmaceuticals, NIH)

oPhase II Ebola vaccine studies (Janssen Pharmaceuticals, Merck, NIH)

Managed 4 clinical laboratories in 4 hospitals and 1 biorepository for sample collection.

Provide in-person/virtual training, presentations as required

Advise and help PI’s on clinical trial initiation, implementation, and other clinical trial management activities

Help and facilitate the monitoring visits/initiation visits/close-out visits with regulatory documents and necessary information

Compile, analyze and report the results of complex sensitive bio-medical procedures in specialized scientific service laboratories in Liberia, Africa

Evaluate results of each experimental or production steps and determine If alternative courses of action are warranted before proceedings and help the local and international PIs to interpret the results.

Assess clinical trial competencies and follow Corrective and Preventive Actions (CAPA) if necessary

Develop SOPs to optimize the lab flow, design protocols for optimal efficiency

Acted as liaison for Leidos biomed and the other sub-contractors (TMG, vendors, repair personnel)

Provide oversight in sub-contract work such as laboratory construction and maintenance

Experience in CRFs, IRB protocols, and electronic documentation

Maintain proper quality control checks and detailed records for experiments, production assays, or tests for clinical trials. Follow CLIA, GCP, GLCP, FDA standards.

Calibrate, set up, validate, maintain, troubleshoot and perform service repairs on immune assay, Elisa automation-Evolis, ran and design runs for HBVe, HIV, HBVsAg, Syphilis, HBVc, TB assays.

Maintain and troubleshoot database issues and send laboratory data to central data management center, troubleshoot LIMS issues

Attend meetings conference calls with different teams including local and international dignitaries from NIH, UN, USAID, WHO, CDC, State Department etc.

Oversee the local biorepository, which holds crucial samples for studies and oversee sample transfers within the labs and to Liberian Institute of Biomedical Research (LIBR)

Maintain sufficient stocks of supplies for all the laboratories

Develop technical manuals for the medical diagnostics instruments

Supervise assembly and bar-coded labeling of laboratory kits

Assist with management, Investigational product dispensing and accountability for Ebola vaccine trials (Z-MAPP and GS-5734 Ebola treatment studies)

Research Technician II/ Automation Technician

C.W. Bill Young Department of Defense, Marrow Donor Program, Rockville, MD 2008-2015

Operated, troubleshot and validated latest Thermo Fisher (One Lambda Inc.) LabXpress Prototype Robotic Automation (High throughput screening), which types around 2500 donors a day

Performed DNA extraction and purification from whole blood and buccal swabs for molecular diagnostic in HLA Processing Section using Qiagen instrument. (EZ1 Advance XL)

Performed PCR and “DNA typing” using Luminex 96 well platforms for Large Volume HLA Typing Section

Operated and troubleshot Luminex FM3D Xmap (reverse SSO DNA typing assays that provide resolution for HLA A, B, C, DRB1, DQB1 and DPB1 HLA typing)

Performed DNA analysis using HLA Fusion software for Bone Marrow Registry Donors

Performed preventive maintenance and regular monitoring for laboratory equipment, devices, and automation platforms

Maintained the DNA, blood, and swab repository for over 860,000 samples

Retrieved DNA, blood and swab samples from on-site and off-site repositories

Calibrated thermos-cyclers bi-annually using a temperature drift monitoring system (DRIFTCON) for yearly validations

Monitored daily temperature of Ultra Low -80C freezers, liquid nitrogen freezers, and refilled liquid nitrogen freezers

EDUCATION

Bachelor of Science in Healthcare Administration: Aspen University, Denver, CO (Magna Cum Laude)

Master of Business Administration in Information Systems (3.81 GPA) (Expected: October 2020)-CAPSTONE: Integrating Emerging Technologies and Mitigating Threats (Small businesses and healthcare facilities)

Studying for PMP certification (Expected: February 2021)

SKILLS

Strong ability to identify and resolve vendor and client issue

Languages: Sinhalese, English, Spanish, Hindi

Project management: Project Libre, Microsoft project

Word processing and publication: Microsoft Word, Microsoft Publisher

Spreadsheets and databases: Microsoft Excel, Microsoft Access

Operating Systems: Microsoft Windows, OS X, Linux

Presentation: Microsoft PowerPoint, Adobe Illustrator

Email: Microsoft Outlook, Google Mail

Photography: Adobe Lightroom, Adobe Photoshop, Adobe Lightroom

Masonry, carpentry, roofing, plumbing, dry-walling, electrical wiring

Computer hardware repair, security and networking

CERTIFICATIONS AND AWARDS

Clinical trial that I supported wins the David Sackett Trial of the Year Award for 2019

https://frederick.cancer.gov/news/ebola-clinical-trial-supported-fnl-receives-%E2%80%9Ctrial-year%E2%80%9D-award

Advanced GCP Training Certificate

Shine Award for CMRP/CRD & Beyond by Leidos Inc., 2019

American Board of Histocompatibility and Immunogenetics (ASHI): Current Topics for Technologists (21.8 CEC’s)

Alfa Wassermann Diagnostic Technologies LLC: Repair and maintenance of the Ace Axel clinical chemistry system

National Institutes of Health: Protection of human research participants

National Institute of Health: Blood borne Pathogens

NIIT: 3D animation

SAFTPAK Shipper training

COMMUNITY SERVICE

Helping orphanages in West Africa to receive funding, food, stationery and food to help them in their day to day activities.

Volunteer for the Commission on Urgent Relief and Equipment (Project C.U.R.E) to bring much-needed medical supplies and equipment into Liberia to treat Ebola survivors.

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