Clinical Research Medical
Resume:
Carmen Arismendy, M.D. CCRC Contact Info
Senior Healthcare Executive Business Development
RIDGEWOOD, NJ 07450
*************@*****.***
www.linkedin.com/in/carmenarism
endy
Summary
Energetic goal-focused Senior Healthcare Executive and Clinical Researcher
with solid qualifications in management and customer relationship within
the pharmaceutical and health market by creating the platform to bring
clinical trials to the health community and rescue the established research
division accounts from failure by bringing new strategies, processes, and
deliverables to grow revenues while capturing quality results across multi-
speciality research studies.
Extensive knowledge of research regulations and assessment skills required
for safe conduct of human research trials, including patient safety,
perform medical review of clinical cases. Fifteen years of top level
management experience in hospitals, clinics, and multi-specialty
organizations. Consistently demonstrates a proven ability to develop new
research business within United States and Latin American markets.
Areas of Proficiency
. Clinical Patient Research Trials
. Internal Management
. Business Development
. FDA Research Regulations
. Quality Assurance
. Pharma Monitoring Auditing
. US Latin Markets
. Recruitment Sales Growth
. Hospital Private Practice
. Strategic Planning
. Project Management
. Delivery Criteria Scheduling
. Flexibility Adaptability
. Detail Oriented Organization
. Relationship Building Skills
Professional Experience
Research and Business Development Director
Jul. 2014 - March 2015
HUMANITY HEALTH NY www.humanityhealth.com
Leads business development growth efforts for a top service provider that
works with patient/subjects, physician investigators and pharmaceutical
companies/CRO sponsors to increase the efficiency, timeliness and quality
of clinical trials to optimize the effectiveness of clinical research.
. Identifies protocols looking for sites in the areas of disease focus:
Cardiology, Respiratory, Diabetes, Nephrology and Gastroenterology while
continuing to grow the MD/PI network.
. Perform Medical Review of clinical cases
. Perform primary evaluation of safety observation, including Adverse Event
and Serious Adverse Events
. Perform aggregate reports and safety analyses, that reports that comply
with regulatory standards
. Hands-on experience in patient and drug safety research, evaluation and
documentation activities
. Develops strong relationships with Sponsors and MDs alike and by working
with both Humanity Health and the local MD office staff to make setting
up and operating studies seamless at these sites and thereby increasing
profits at each location.
. Creation of a business development processes so all business development
activities while improving and implementing the processes.
. Takes a common sense approach to protocol identification, Sponsor/CRO
solicitation and working with Investigators/coordinators.
. Recruitment strategy execution specific to Latino/Hispanic markets aimed
at MD / PI Network growth, approaching MDs in the HH geography to assess
their viability as PIs, and identifying clinics in relevant areas of
therapeutic focus
Founder
Dec. 2008 - Jul. 2014
ARYSMED NY, NJ www.arysmed.com
Provide physicians with resources, information, and expertise in clinical
research in order to foster and facilitate the clinical research enterprise
within the private practice industry.
. Maintain protocol control and accountability of the product,
Investigational Drug, Vaccine or Device; Management of EDC System which
holds subject data and runs multiple data queries for accuracy.
. Work with, Physicians and pharmaceutical related administrators to
cultivate relationships; negotiate contracts with department heads in the
pharmaceutical market.
. Leading the marketing/recruitment patient campaign from the various
clinical trials and making sure that these campaigns were compliant with
the required regulations and industry standards.
. Lead all studies in accordance with all applicable federal, state/local
laws, regulations/guidelines and rules governing federal/state healthcare
programs; Oversee administrative and clinical facilities.
. Provide expertise around qualified staffing/training and elements, for
successful, multi-tier recruitment strategies
. Managing the entire clinical Research operation from the company research
network
. Managing remotely the research network as well as the clinical research
staff throughout NY and NJ area
. Institutional Review Board Communication throughout the trial including
any changes to the approved research.
. Accurately reports Safety Events and Safety Recording and Reporting of
all relevant safety information.
. Building successful relationships with the pharmaceutical companies and
research staff within our network
Research Director Jan. 2008 - Dec. 2008
NY UROLOGICAL ASSOCIATES NY www.nyurological.com
Responsible for business development, internal management, and quality
clinical input/medical monitoring services:
. Communicate with Clients/Project Managers to promote delivery of the
project schedule while ensuring that projects are adequately equipped
with the right resources and tools to meet high quality standards.
. Management of Oncology focused medical monitoring. Analyze current
research related to the therapeutic areas involved in sponsored clinical
development; Interact with Regulatory Authorities/Sponsors/Medical
Affairs Groups on issues related to protocol development review.
. Support business development efforts such as: presentations, client
prospecting, company representation at meetings, proposal review/writing,
and scientific publication contributions.
. Manage personnel activities including: guidance for professional
development for staff, training/education for ICH guidelines/Oncology
therapeutic regulatory guidelines, and decision-making guidelines
throughout team structures
Clinical Researcher Manager Jan. 2003 - Dec. 2007
NYU HOSPITAL NY www.med.nyu.edu
Responsible for ensuring Anesthesiology record standards meet current State
and Federal regulatory agency across all hospital policies within all GCP,
ICH and FDA regulations. Responsible for quality assurance for entire
patient database. Coordinate related meetings, oversee projects/quality
reviews and prepare financial balance sheets to effectively measure annual
capital/operating budgets for the all-inclusive health care facilities
including:
. Review individual safety reports for investigational products (IND) for
medical content, regulatory status, signal detection, and expedited
reporting. Coordinate and monitor SAEs in compliance with the IRB and
regulatory offices. Schedule/maintain participant's documentation for
sponsors (CRFs).
. Responsible for narrative writing, medical evaluation of a case,
reconciliation of databases, reviewing of protocols. Creation of Clinical
Research Studies from protocol developments through trial closure.
Establish, implement and document research protocols, for all clinical
trials, and all performed in compliance with GCP, ICH and FDA
regulations. Maintain study database to in compliance with FDA
regulations. Perform NIH studies, coordinate interviews of clinical
research trial participant's. Execute medical research protocols to
determine volunteers study eligibility.
. Maintain clinical/regulatory files, monitor patient's study progress to
fulfill protocol/sponsor requirements. Prepare and analyze regular
reports of research activities. Ensure that audit programs are in place
to evaluate compliance with SOPs, protocols, and relevant FDA
requirement/inspections and sponsor audits. Supervise a small staff of 3-
5 team members, to ensure compliance with the audit program and report
review.
Research Manager Quality Assurance May. 1999 - Nov. 2002
MOUNT SINAI HOSPITAL NY www.mountsinai.org
CARDIOLOGY & BEHAVIOR INTEGRITY UNIT, Mar. 2001 - Nov. 2002
. Preparation of clinical development plans and institution of clinical
protocols and evaluation of results, reports, questionnaires, interviews,
and presentations; oversee progress of the studies, IRB Protocol
Planning, budgets and expenditures to meet compliance standards for all
relevant laws, regulations and guidelines.
. Database maintenance within proprietary software applications, including
continuous quality improvement using best practices for rapid performance
productivity.
DERMATOLOGY DEPARTMENT, May. 1999 - Feb. 2001
. Conduct laboratory testing according to standard formats for specimen
collection and processing; Implement procedural guidelines to perform
tissue processing, histology and H-E staining; Instrument operation,
troubleshooting, result reporting and record documentation using computer
applications; Follow safety requirements, quality control monitoring,
prioritizing testing, and maintenance of patient care standards for
maximum efficiencies; Communication of specimen requirements, reference
ranges, and tissue test results to nurse staff.
Pharmacology Department Assistant Research Professor of Medicine Jan.
1991 - Dec. 1992
UNIVERSITY OF CARTAGENA COLOMBIA, SA www.cartagenauniversity.edu
Clinical Trials
. PFIZER, Hypercholesterolemia and CV Outcomes
2014-2015
. PAREXEL, Diabetes and CV Outcomes
2014-2015
. SYNERGY, Chronic Constipation
2014
. TAKEDA, Gout
2014
. Novartis, Myocardial Infarction Protocol No. CACZ885M2301 2013
. NOVO Nordisk, Diabetes Type 2 Dual Study 2013
. Merck, Diabetes Type 2 2013
. Merck, Diabetes Type 2 2012
. OREXYGEN, Weight Loss 2012
. SYNERGY, Constipation 2012
. ARDEA, Gout 2012
. COPD Summit, GSK 2011
. PAREXEL, Asthma 2011
. Covance, PKD 2011
. PRA International, SECURE 2010
. EISAI, Inc., Prostate Cancer 2009
. EISAI, Inc., GERD 2009
. National Institutes of Health (NIH), White Coat 2005
. National Institutes of Health (NIH), Sleep Heart Study 2005
Education, Certifications
. Certificate, CCRC 2008, 2012, 2014, 2016
. Certificate, HAZMAT 2008, 2012
. Certificate, Investigator Participation 2008
. Certificate, CITI Tutorial 2007
. NYU Hospital, HIPPA Training 2003
. Certificate, Mount Sinai School of Medicine Protection of Human
Subjects in Research 2001
. University of Cartagena Medical School, Colombia SA Medical Doctor,
Surgeon 1991
Functional Skills
. Languages English, Spanish
. Computer Microsoft Office, Excel, PowerPoint, Word, Outlook, Access,
Windows
. Interests Health, Medical, Wellness, Clinical Trials, Research,
Evolution in Medicine and Treatment
References
Available Upon Request.
Contact this candidate