Elizabeth Polo

General Manager at TRI CRO S.A.C. (Technical Resources International, Inc. Lima - Peru) @ Technical Resources International, Inc.

About

Elizabeth Polo, M.D., CQA, CCRP, has over 17 years of experience covering the pharmaceutical, NIH and clinical arena, including extensive working knowledge of GCP, GLP, ICH E6 GCP, HSP and 45CFR46. Experience in clinical research, quality auditor and medical management. Providing scientific support to opinion leaders, physicians, researchers and other stakeholders including sales force. Experience in various inspections including: EMA, and MoH Inspections at Peru, Chile, Ecuador and Brazil. Providing QM oversight to multiple government and commercial clients. Therapeutic areas of expertise include oncology (monoclonal antibodies), cardiovascular (diabetes), neurology (CNS), infectious diseases, and immunology. Speaks Spanish, Portuguese and English.

Country

City

Peru

Industry

Research

Skill

Auditoría, Investigación, Liderazgo, Auditorías internas, Comunicación

Experience

General Manager at TRI CRO S.A.C. (Technical Resources International, Inc. Lima - Peru)

Technical Resources International, Inc.

2019-9 - Present · 7 yrs

Peru

Full service CRO especially knowledgeable about developing countries’ regulations and cultural differences, developing effective remote (central) monitoring procedures and tools.

Independent Consultancy

Freelance, self-employed

2016-5 - Present · 10 yrs 4 mos

Wide experience in Medical Management, Quality Auditor, Clinical Research, Clinical Monitoring and Regulatory Affairs for clinical trials across Latin America and Africa.

Medical Scientific Liaison

Grünenthal Group

2019-1 - 2019-3 · 3 mos

Peru

Providing scientific support to opinion leaders, physicians, researchers and other stakeholders. Provide medical training to researchers / independent doctors and company staff. Respond to requests for scientific information requested and unsolicited interaction via one by one or in group discussions. Training disease and product.

FHI360 Contract CRA

FHI 360

2017-6 - 2018-9 · 1 yr 4 mos

United States

Clinical Monitoring for Zika clinical trial across Latin America sponsored by National Institute of Health (NIH) and the Vaccine Research Center (VRC) from the United States of North America.

Clinical Research Associate and PSI CRO Peru´s Legal Representative

PSI CRO

2011-2 - 2016-5 · 5 yrs 4 mos

Peru

Develop Clinical Trials in Peru in accordance to ICH/GCP, local regulations and corporate policies. Interaction with health authorities, academic and medical community. Also responsible to oversee site selection and internal allocation of studies in Peru, Responsible to provide high level scientific support for external customers for a given therapeutic area and product. Providing scientific support to opinion leaders, physicians, researchers and other stakeholders. Provide medical training to researchers / independent doctors and company staff. Respond to requests for scientific information requested and unsolicited interaction via one by one or in group discussions. Training disease and product.

Clinical Trial Monitor

Roche

2008-9 - 2010-8 · 2 yrs

Peru

Identify and develop relationships with country KOLs; provide suggestions for clinical research; site selection; site initiation; site close-out; site routine monitoring; CRF review and source data verification; sites and vendors communication; site management; visit reporting; SAE processing and follow-up; feasibility support; client communication; training of site staff; training and mentoring of project team; ensuring compliance with national regulations, GCP, protocol and procedures; EDC; audit preparation, participation and follow-up.