Medical Manager
Resume:
Nadeeka Randunu
**********@*****.***
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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