Lesly Suarez Caceres

International Center for Public Health

Activities:

• STATA data exploration,
• HIPAA, CITI, IATA cat b certificates
• BSL2-BLS3 lab certification
• Select Agent-Insider Threat
• Participant screening and enrollment (EPIC/REDCap), Patient FUP
• Managed inventory and supplies to ensure materials were available when needed.
• Specimen collection and processing (including venipuncture)
• Develop CRFs
• Shipping process
• Regulatory compliance
• MTF organization
• Regulatory applications, eIRB submissions, reports
• Protocol/SOP development
• Coordinated investigator meetings, conference calls, and site initiation visits as needed.
• Gathered and reviewed study data.
• Collaborated closely with team members to achieve project objectives and meet deadlines.
• Sites: Rutgers University Hospital/Lattimore Clinic)

Studies:

• Translating a novel, streamlined CRISPR-Cas12/13 system for the detection of tuberculosis
• Harnessing the human humoral response against TB
• Wastewater surveillance with CRISPR Cas 12/13 (Uganda/Rutgers/Princeton Collaboration)
• Development of a highly-multiplexed CRISPR-based TB drug susceptibility test (Fudan/Princeton/Rutgers collaboration)

• Focus on Healthcare Protocols
• Website: www.grc-health.com

Study:

• Peru Alzheimer's Disease Initiative (PeADI) - Sponsor: University of Miami

Activities:

• Coordinate shipping process within study sites
• Regulatory applications/compliance
• MTF organization
• CRFs review through all sites
• eIRB submissions, reports
• Coordinated investigator meetings, conference calls, and site initiation visits as needed.
• Collaborated closely with team members to achieve project objectives and meet deadlines.

Office:

• General Office for Research and Technology Transfer - OGITT

Curricula:

• Research bioethics
• Investigational product safety monitoring
• Clinical trial inspections
• Evaluation of clinical trials

Institute of Tropical Medicine 'Alexander Von Humboldt' Tuberculosis Unit

UPCH Delegated roles in time, from current to previous:

• Study Coordinator. Period: 2017-2022
• Field Coordinator. Period: 2017-2022
• Laboratory QA. Period: 2016-2017
• Laboratory analyst. Period: 2015-2016

Participation in UPCH research studies:

Study Title:

• Multicenter clinical study to evaluate the efficacy of Bioneer Q-RFIA PCR kit intended for use with the IRON qPCR platform to detect MTB and resistance to rifampicin, isoniazid, fluoroquinolones, and aminoglycosides. Role: Study coordination / Field Coordination.
• Validation of a rapid molecular test for the diagnosis of covid- integration with tuberculosis diagnosis: Cough analysis based on 19 AI for the detection of tuberculosis and COVID-19. Delegated Role: Study coordination.
• Ground truth' of Mycobacterial Lipoarabinomannan (LAM) presence - Collection, Storage & Distribution. and Sub-study Title: Use of the digital stethoscope. Pilot feasibility study Delegated Role: Study coordination / Field Coordination.
• TB reference materials (TBRM)- collection, storage & distribution. Delegated Role: Study coordination.
• Prospective multicenter study to evaluate the diagnostic accuracy of the Truenat tests in the centers designated for their use. Delegated Role: Field coordination.
• CDC TBTC Study 32: OPTIQ - Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB. Delegated Role: Quality control - Laboratory Analyst Biologist.

Activities

• Monitored expenditures against grant budgets to ensure efficient use of funds allocated for research activities.
• Developed materials for outreach activities designed to increase awareness about the project among target audiences.
• Hired and trained staff while managing all research projects.
• Created detailed tracking systems to monitor subject recruitment rates and completion rates of surveys and interviews.
• Educated participants on studies and anticipated outcomes.
• Participated in weekly team meetings to discuss progress on current projects and plan future initiatives.
• Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
• Supervised documented data accurately, ensuring the integrity and reliability of research information.
• Coordinated the recruitment of study participants through various channels, such as targeted advertisements and referrals from community partners.
• Analyzed quantitative survey data using statistical software programs such as SPSS or STATA.
• Reviewed consent forms for accuracy and completeness prior to participant enrollment in the study.
• Conducted screening interviews to determine eligibility of possible subjects.
• Maintained accurate records of all documents related to the research process, including consent forms, interview notes, survey results.
• Kept patient care protocols and clinical trial operations in compliance.
• Collaborated with other research teams to share resources, coordinate efforts, and ensure quality control across multiple projects.
• Adapt protocols, prepared equipment and purchased materials to coordinate administrative functions in support of planned studies.
• Collected, processed and delivered specimens from trial participants.
• Updated and maintained databases with current information.

Laboratory of Mycobacteria

Activities:

• Perform MGIT/LJ cultures/ Genotype
• Microscopy reading ZN
• Media preparation
• Results report

Ad honorem rural service for health professionals: Lince health center, Lima, Peru

Research and Development Laboratories

Activities:

• PCR/DNA extraction

Laboratory of Mycobacteria

Activities:

• Perform MGIT/LJ cultures/ Genotype
• Microscopy reading ZN
• Media preparation
• Results report

Activities:

• Tested antibiotic sensitivity patterns of bacteria; evaluated efficacy of different antibiotics against specific pathogens.
• Identified bacterial cultures from specimens; isolated pure cultures using aseptic techniques.
• Maintained accurate records of all experiments conducted in accordance with established guidelines.
• Managed inventory and supplies to ensure materials were available when needed.

Department of Clinical Pathology and Blood Bank

Laboratory rotation: Immunology, Microbiology and Parasitology, Blood Bank, Biochemistry, and Fertility laboratory.