Gonzalo Suarez MD, PHD
Phone : 612-***-****
Professional Summary: To contribute to the Clinical Research field where I will be able to help the whole team comply with all the recruitment process, required regulations, Case Report Forms, Reporting Adverse Events, serve as a Liaison between IRB and the Trial site and prevent unnecessary delays in the initiation and guaranteed the timely completion of clinical trials also prevents any protocol deviation and reassure FDA regulatory compliance.
Summary of qualifications:
As a OB/GYN attending physician ( 1992-2017)
Office Consultation, dealt with several Obstetric and gynecological diseases, knowledgeable on Obstetric ultrasound, Delivery and Operating Room duties, served as member of the Board of Directors in my hospital during 2011-2015, I managed under my supervision 125 employees of Clinica El Avila. Extensive training experience, supervising personnel and coordinating activities among members of healthcare teams.
As a Clinical Research Assistant ( 2018)
Experience looking over regulatory and clinical protocol compliance to avoid deviations or redundant work.
Contributed to develop study materials such as patient brochure, patient recruitment material, etc.
Assisted on Inform Consent Documents creation and reassure that all ethical and other key elements are included.
Experience with selection, qualification and start up of the Clinical Trials sites.
Served as a Liaison between vendors services, labs, IRBs, sponsors and PI.
Handles clinical Data into EMR and CRF and look out for accuracy and completeness.
Contributed to monitor and audit all stages of the Trial .
Trained external clinical professionals to ensure compliance with the ed activities.
Vast Experience on Medical Terminology.
Clinical Research Experience.
Strong Medical background.
Trained as a Clinical Research Coordinator.
Trained on Good Clinical Practices.
Knowledgeable administering Informed Consent and carrying out the recruitment of subjects for Clinical Trials.
Managed Clinical Data, entered into electronic medical records and case report Forms.
Planned safety strategy for the prevention of adverse effects during studies and designing protocols for reporting adverse events to the IRB’s.
Detection and reporting adverse events of experimental protocols to participants, Principal Investigators, primary care physicians and IRB.
Collected data on medications and evaluated their effects on experimental protocols.
Good capacity to manage, follow standard operating procedures and execute research projects to full completion and complete understanding of good clinical practices.
Completion and maintenance of Regulatory Binder.
Respectful and compliant with IRB protocols, HIPAA guidelines and FDA regulations.
Knowledgeable in the use of all Microsoft office programs and extensive knowledge of In Core, EPIC programs and EMR ( electronics Medical Records).
Fluent in English and Spanish.
4 articles published in peer reviewed journals
1 book chapter regarding puerperium infections
Contributing to one Clinical Trial “ Use of Entresto Sacubitril/Valsartan for the treatment of Peripheral Arterial Disease”, NCT02636283, at Minnesota University, under the supervision of Dr. Otto Sanchez.
Clínica El Avila, Caracas, Venezuela, OBGYN Dept, January 1992 to October 2017.I worked as a OB/GYN attending physician with office consultation duties, Delivery Room activities and Operating Room active role. Served as a member of the Board of Directors ( 2011-2016) of the Clinica El Avila Hospital.
Worked as a Clinical Research Assistant contributing to one Clinical Trial “ Use of Entresto Sacubitril/Valsartan for the treatment of Peripheral Arterial Disease”, NCT02636283, at University of Minnesota, under the supervision of Dr. Otto Sanchez since February 2018 to October 2018. During this period I contributed mainly enrolling subjects to the Clinical Trial, Consenting subjects, managing medical data, filling out electronic medical records and case report forms, reporting adverse events and served as a liaison between the Principal Investigator and the IRB and oversee the compliance with Federal Regulations and Good Clinical Practices.
Ph.D in Obstetrics and Gynecology, Universidad Central de Venezuela, Caracas, Venezuela,1986- 1989
M.D, Universidad Central de Venezuela, Caracas, Venezuela, 1978-1984
Clinical Research Coordinator training certificate at Northwestern University Clinical and Translational Science Institute (NUCATS, Chicago, Il).
Collaborative Institutional Training Inicative ( CITI ) Good Clinical Practice course, approved.
American Board of Surgical Assistants ( ABSA), First Surgical Assistant Certified, Wisconsin, US,2017
Nuchal Translucency Determination, Fetal Medicine Foundation, Caracas Venezuela (2007)
First Trimester Screening for Aneuploidy, Reina Sofia Clinic, Bogota, Colombia ( 2007)