Clinical Research Customer Service

ISAAC FRANCE New York, NY

347-***-**** *************@*****.***

SUMMARY: A seasoned, passionate, highly skilled professional with the goal of helping individuals by attaching compassion, honesty, flexibility, leadership, discipline, attention to detail and the willingness to learn at any opportunity. Added to the above are the application of ethics, SOPs, ICH/GCP guidelines to the experimental design and conduct of clinical research trial to ensure subjects’ safety and well-being as well as the integrity and reliability of the data which is collected from the subjects for use to improve and save lives.

SKILLS:

Mathematics

Statistics

Microsoft Word

Microsoft Excel

Microsoft Powerpoint

Writing Research Reviews

Writing Grant Proposals

Customer Service

Electrocardiograms

Blood Sugar Measurement

HIPAA/PHI

ICH/GCP & GDP

CRF Creation

Data Collection & Analysis

Fluid Input/Output Measurement & Recording

Informed Consent

Crisis Prevention & De-escalation Techniques

Multi-tasking

Data Management

Clinical Trial Protocols

GDP following ALCOA-C

Maintaining Regulatory Binders

Housing Essential Documents

Quality Assurance

Monitoring & Query Resolution

Identification & Reporting of AEs & SAEs

FDA Regulations 21 CFR 11, 50, 54 & 56

Clinical Trial Operations

Experience with R (including R-commander)

Experience with use of “Access”

Some knowledge of C++

EDUCATION:

Clinical Research Fastrack Scottsdale, AZ • June 2019

Certificate of Completion • 228 Hours

Studied the role of CRC in relation to Federal Regulation; ICH/GCP, GDP; preclinical and clinical stages of drug development; phases of clinical trials; recruitment and enrollment of subjects as well as recording of data and reporting of events-AEs/SAEs.

New York University (NYU) New York, NY • Sept. – Dec. 2018

Clinical Documentation Improvement Specialist (CDI)

Studied coding techniques both ICD10 CM and ICD 10 PCS; principles of CDI (involves identifying shortcomings in documentation and writing queries to that effect.) Introductory CDI (involves the rules and ethics of CDI.) Budgeting and reimbursement (Medicare, Medicaid, HIPAA, PHI.)

Icahn School of Medicine, Mount Sinai Manhattan, NY • Sept. 2015 – June 2017

Postgraduate Diploma in Clinical Research

Ethics of research (IRB, learning how to make impromptu decisions about patients.) Research including study designs, preclinical and clinical stages of drug development, phases of clinical trails, determination of right dosage using micro-dosing techniques, epidemiology, writing of research hypotheses and research questions, using statistical methods in making decisions in research (use terms as margin of safety, inferiority and superiority.)

CUNY, College of Staten Island Staten Island, NY • Feb. 2009 – June 2013

Master of Science, Neuro Science

Cell biology, anatomy and physiology of the human body, information disseminating in nerve sells through action potential, neuroanatomy and neuropsychology, brain structure and brain parts (including Broca’s and Werniki areas;) brain parts affected in disease conditions as in psychiatric diseases, functions of different brain parts and disease that manifest when they are affected (as in Parkinson’s and Huntington diseases;) research methodology, genetics studies including diseases and role of environment in the differences in behaviors of individuals.

University of Cape Coast Cape Coast, Central Region, Ghana • Oct. 2000 – June 2003

Bachelor of Education, Mathematics

Included teaching and how learning takes using psychology; statistical methods; school management and administration; writing and analysis of test items.

EXPERIENCE:

Internship

NJ Heart Linden, NJ Sept 9-26, 2019

Prepared patients chart beginning screening for clinical trials

Learned how to make entries from patient’s chart onto the EDC (Electronic Data Capture)

Learned how to use the IVRS to facilitate patients visits, allocation of medication, confirm visits and shipment of medication.

Learned how to make entries from patient’s chart onto the EOT form (End of Trial Form)

Learned how to manage blood products collected to be sent to the lab and which included how to handle frozen blood products.

Used the inclusion and exclusion criteria to select patients for screening for the clinical trials.

Shadowed the incumbent coordinator to receive and work with the patient for the end of trial activities.

Bellevue Hospital Center Manhattan, NY

Behavioral Health Associate June 14 – Present

Bellevue Hospital Center Manhattan, NY

Nurse Aide, Nursing Psychiatry Aug. 2010 – 2014

Bellevue Hospital Center Manhattan, NY

CNA, Non-Invasive, Cardiology Oct. 2008 – Aug. 2010

Richmond University Medical Center (RUMC) Staten Island, NY

CNA Nov. 2007 – Oct. 2008

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