Manager Medical

Carlos Quintero

I am a physician with clinical and site management experience in the implementation

of various clinical trials in the areas of Infectious Diseases and Oncology with more

than eight years of advance scientific training.

Miami, FL

********@*******.*** - 305-***-****

WORK EXPERIENCE

Director Clinical Operations

Advanced Pharma CR (APCR) - Miami, FL - 2012 to June 2013

Direct and manage the clinical research staff as well as oversee the day-to-day operations of the research

clinic. Responsible for hiring, training and mentoring of Clinical Research Nurses, Study Coordinators, and Data

Managers. Ensure consistent practices and compliance with APCR procedures and policies, as well as FDA

and GCP requirements. Provide clinical research expertise for the implementation of research protocols in the

clinic workflow. Work constructively with CEO, VP of Operations, Executive Medical Director, Director of Finance,

Director of Marketing and all other areas of senior leadership to provide clinical direction and resolve issues and

concerns. Represent APCR at national meetings, liaison between the sponsor and Principal Investigators.

Clinical Content Manager

Institute for Medical Education & Research (IMER) - Miami, FL - 2012 to 2012

Responsible for assisting the Medical Director on ensuring the quality of all nursing and medical education

programs. Ensure the accuracy of scientific content of all educational programs, verify that primary sources

support facts asserted, ensure that content is presented clearly and concisely, ensure accuracy of clinical content,

including use of current evidence-based data, confirm that studies are cited and referenced correctly. Recommend

changes to correct errors discovered during the content review by collaborating with the clinical leadership. Liaise

with faculty regarding activity content; work with internal team members to ensure that project milestones are

met. Remain current on oncology topics by attending conferences and reading trade journals

Clinical Research Team Lead

University of Miami Sylvester Comprehensive Cancer - Miami, FL - 2011 to 2012

Lead and supervise the team members in collaboration with the Principal Investigators, conduct all aspects of the

clinical trial under the supervision of the PI. Evaluate and adjust workloads of CRCs and Regulatory Administrator.

Resolve personnel issues, conduct performance appraisals of staff. Participate in the mentoring, coaching and

disciplinary process of team personnel as well as termination of employment procedures. Identify educational

opportunities for team members. Manage an assigned set of patients accrued to multiple research protocols

to assure efficiency and regulatory compliance. Monitor compilation, registration, submission of data, study

compliance; ensure affective data flow associated with research protocols. Pharmacovigilance responsibilities

along with AE’s and SAE reporting to the FDA. Member of the team that designs, develops, evaluates and

determines feasibility of protocols. Prepare protocol documentation packages including development of ICF for

IRB submissions. Collaborate on the design and writing of protocols, case report forms. Monitor study protocols

for deviations and assess trends for amendments. Liaison between sponsor and clinical investigator.

Sr. Clinical Research Coordinator

University of Miami Sylvester Comprehensive Cancer - Miami, FL - 2008 to 2010

Assist in the design of studies. Develop, verify and implement procedures to accomplish research goals.

Implement research protocol and monitor/participant adherence to protocol. Take action to correct deviations

or other problems. Verify accuracy of research data and monitor data quality. Maintain IRB and sponsor

correspondence. Notify regulatory personnel of protocol amendments, safety reports/serious adverse events, etc.

in compliance with regulations. Pharmacovigilance responsibilities along with AE’s and SAE reporting to the FDA.

Work independently in institutional studies and collaborate with a team in pharmaceutical sponsored studies. Data

management, experience in Oracle, Rave, InForm, WebEZ, Aries, Velos. Responsible for coordinating clinical trials

in the Thoracic Oncology and GI/GU site disease group. Develop and complete case report forms, flow sheets

of study events, and data collection forms, and enter data. Prepare for monitor visits. Screen and enroll research

patients. Maintain study records and prepare regulatory submissions.

Interim Manager Research Unit

University of Miami -Miller School of Medicine - Miami, FL - 2008 to 2008

Managed day to day operations leading a staff of 6 CRC’s and 2 phlebotomists. Acted as a liaison to

pharmaceutical company personnel, community physicians and other University of Miami Departments and

Divisions. Worked closely with the Principal Investigators and Center director.

Post Doctoral Associate

University of Miami -Miller School of Medicine - Miami, FL - 2006 to 2008

Prepared study protocols for IRB submission; wrote informed consent according to FDA, IRB, ICH-GCP

guidelines. Counseled patients and their support system concerning; liver disease, alternative treatments,

study protocol requirements and risk/benefit of clinical research trials. Conduct informed consent process in

accordance with standard operating procedures. Schedule patient study visits ensuing that physical exams

are completed, medications dispensed, and information collected in regards to adverse events, study drug

reaction and order laboratory tests. Order, dispense, collect and maintain records of study medication and assess

patient compliance. Communicate with study Principal Investigator and Research Unit Manager regarding patient

recruitment, study progress, patient status and any adverse events. Attend divisional research trainings and in-

services. Represent study site at national/international investigator/ coordinator meetings.

SKILLS

clinical research, clinical trials, oncology, regulatory submissions, data management, GCP, institutional research,

data collection, life sciences,

ADDITIONAL INFORMATION

SKILLS

Computer Proficiency

MS Word, Excel, Outlook, and Power Point

Proficiency in Data Management Software.

Oracle, Rave, InForm, WebEZ, Aries, Velos

General Medical Skills

Patient interview, physical exam, vital signs, phlebotomy, medical terminology.

Medical Skills

Designing and developing epidemiological studies, questionnaires, networking with community

members, screening, enrolling, administering questionnaires, obtaining informed consent,

scheduling data collecting procedures.

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