Professional Summary

I am a Physician with over *5 years of experience diagnosing, treating and monitoring patients receiving Oncology, Hematology and Infectious Diseases treatments. Worked for a Contract Research Organization (CRO) specialized in Phase I and Phase II Clinical Trials for Pharmaceutical Industry. I am currently working in Phase III and IV Clinical Trials for the Pharmaceuticals and Medical Devices Industry. Responsible for the safe and effective implementation of Clinical Trial Protocols, monitoring that studies are conducted, recorded, and reported in accordance with FDA Guidelines, GCPs, standard operating procedures (SOPs) and the study protocol, and all applicable regulatory requirements.

Work History

December 2016 – Present. Senior Certified Clinical Research Coordinator. Mercy Research. Mercy Hospital. St. Louis, Missouri. U.S.A.

Prepare documents for review by sponsors, monitors and regulatory authorities, as necessary. Serve as point of contact for all Clinical Research Professionals.

Review with principal investigator the inclusion/exclusion criteria, overalls structure and requirement of each protocol. Plan and development of source documents as required, subject recruitment strategies, randomization procedures ensuring that protocol and guidelines are followed.

Review and verify source documents. Ensure timely and accurate CRFs completion for each study subject.

Assist in providing monitors and auditors with completed CRFs, medical records, lab data, and source documents for review as needed.

Assess, record and report all AEs, SAEs, etc. to the principal investigator, sponsor, monitor, IRB as outline in the protocol and in a timely manner.

Assist with study close out, ensure that all documentation is appropriately complete, store study files in a permanent and safe location according to protocol and guidelines.

Nov 2015 – December 2016. Assistant Screening Coordinator (CRC). Pharma Medica Research Inc. St. Charles, Missouri. U.S.A.

Collaborate with Clinical Director and Principal Investigator to plan and execute multiple Phase I and Phase II clinical studies. Assist meetings and protocol review.

Create and review clinical project documents according to GCP Guidelines, the protocol and SOPs, including, but not limited to, source documentation forms and guidelines, monitoring that SOPs and guidelines are followed. Ensure necessary laboratory supplies and equipment is available. Conduct telephone interviews to determine volunteer eligibility. Schedule screening appointments to recruit volunteers for studies. Obtain informed consent and HIPAA authorization, conduct screening interview, and enroll volunteers. Confirm volunteers meet the eligibility criteria.

Monitor and maintain source documents and regulatory documentation of clinical trial. Ensure quality of data on Case Report Forms (CRFs), adverse event reports, drug accountability logs, and other study related communications.

Develop SOPs deviations and protocol deviations as required, address QC/QA audits, ensure each volunteer file is prepared and completed with all the necessary documentation, follow-up with volunteer medical results.

Provide study status updates to management, project management and team members. Including interaction to resolve any issues and facilitate project timelines.

Train, supervise and evaluate clinical staff on completing CRF’s and study documents and conducting study related procedures in compliance with the Protocol, SOP’s, GCP’s and other applicable regulatory requirements.

June 2014 – Nov 2015. Medical Screener. Pharma Medica Research Inc. St. Charles, Missouri. U.S.A.

Conduct telephone interviews to determine subject eligibility. Obtain Informed Consent from volunteers by providing clear explanation and answering questions or concerns.

Perform screening procedures such as blood sample collection and shipping, vital signs, ECGs, etc., according to study protocols. Train, supervise and monitor staff to ensure all study procedures are in compliance with Protocol, GCP’s, and SOP’s. Ensure that the safety and wellbeing of the volunteers is guaranteed throughout the process.

Properly complete documentation of study activities according to GCP, SOP guidelines and FDA regulations.

September 2013 – May 2014. Sales Representative. Charter Communications. St. Louis, Missouri. U.S.A.

Managed customer interactions professionally and efficiently. Extensive use of telephone communications. Effectively addressed customer questions, complaints and concerns. Complied with company and call center policies and procedures.

January 2012 – December 2012. General Practitioner. Social Insurance Fund of Panama. Day Hospital. Panama City, Panama.

Worked as a General Practitioner monitoring patients while receiving antibiotics, chemotherapy and biological treatments. Monitored patients participating in Phase IV clinical trials while receiving their correspondent treatments.

Worked as a General Practitioner providing pain management treatment to palliative care patients.

May 2010 – December 2011. General Practitioner. Social Insurance Fund of Panama. Polyclinic President Remon. Panama City, Panama.

Worked as a General Practitioner at the Dispensary Area treating and diagnosing patients with minor trauma and other emergencies. Supervised healthcare professionals of all areas of expertise during my shift, and other administrative assignments.

December 2008 – January 2013. General Practitioner. National Cancer Institute(ION). Panama City, Panama.

Worked as a General Practitioner treating, diagnosing and monitoring patients with cancer related maladies while receiving biological therapies, radio and chemotherapy, and palliative care, providing quality of care.

June 2007 – April 2009. General Practitioner. Integrated Medical Emergencies (EMI). Panama City, Panama.

Worked as a General Practitioner responsible of an emergency ambulance team of expert paramedics. Diagnosing and treating medical emergency cases. Improving my team work skills by being around different healthcare professionals.

January 2006 – April 2010. General Practitioner. Integrated Hospital St. Michael the Archangel. Panama City, Panama.

Worked as a General Practitioner at an Emergency Room treating and diagnosing patients. Supervised healthcare professionals of all areas of expertise during my shift, and coordinated different hospital activities (emergency surgeries, critical patients care, public relations, customer care, press communications, etc.).

Internship

October 2004 – October 2005. Health Ministry. Nicolas A. Solano. Medical Internship. La Chorrera, Panama

March 2003 – March 2004. Health Ministry. Saint Thomas Hospital. Medical Internship.

Panama City, Panama

Education

Doctor in Medicine and Surgery. Latin University of Panama. Panama City, Panama. 2002

Licences & Certificates

Certified Clinical Research Professional (SOCRA) – July 2017

Registered Medical Assistant (A.R.M.A.) – August 2016

Basic Life Support (BLS). American Heart Association – January 2017

Advanced Life Support (ACLS). American Heart Association – February 2017

NIH – Protecting Human Research Participants – December 2016

21 Code of Federal Regulations (CFR) Part 11 – December 2016

Mayo Medical Laboratories - 49 CFR172.700/IATA 1.5 Training – December 2016

NIH – FCOI Training –January 2017

CITI Program -Good Clinical Practices (GCP) – January 2017

CITI Program – CRC – January 2017

Skills

Knowledge of informed consent process, clinical research and medical terminology

Good written and verbal communication skills in English and Spanish (native) language

Ability to travel domestically and internationally as required and a valid driver’s license

Proficiency in use of Microsoft Word, PowerPoint, Outlook, Excel and Publisher

Other: Oracle, Trial Explorer, Trial Master, CDM, Epic, Medidata, IMedNet, Citrix, IXRS/IVRS

Organizations & Memberships

New England Journal of Medicine – September 2012

Society of Clinical Research Associates (SOCRA) – June 2016

The American Registry of Medical Assistants (A.R.M.A.) – June 2016

American Heart Association – January 2017

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