Robin Hutchens
Senior CRA @ Abeona Therapeutics
About
Clinical and professional CRA with extensive experience in both medical devices and pharmaceutical clincal studies. Focusing now on Cutting Edge Technology which incorporates disease process in novel, unique ways... better devices that target the process; drug discovery and development: targeted delivery systems, vaccines and others.. My continued Professional Goal is always looking for the best I can give to my clients. Trying to make a difference in their lives and mine. Always interested in Medical Devices, Women's and Elderly Issues, Start- Up Companies and International projects. Specialties: Writing SOPs, Designing DataBases, Subject Diaries/Calendars for drug compliance. Patient Teaching and Medication Compliance, Tracking of Data for accurate reporting and submissions. ICH and GCP Guidelines. Writing Abstracts for submissions Interested in both Medical Device Clinical Trials and Pharmaceutical Clinical Trials. Competent in the following systems: Rave, Medidata, Velos, PowerChart, BioClinica, Blue Sky, Oracle, Oracle Clinical, TrialMaster, StudyMaster, CTMS, TNT, MS software, UChart, IVRS, IXRS, Unix, Inform and others.
United Arab Emirates
Dubai
Pharmaceuticals
Home Care, Biomarkers, Drug Development, FDA GMP, Pivotal, Travel, Clinical Site Management, Study Monitoring, OneNote, Gene Therapy, MHRA, Presenter, Oral Communication, Electronic Data Management, Document Management, Good Manufacturing Practice (GMP), Corrective and Preventive Action (CAPA), Regulatory Reporting, Global Regulatory Compliance, Cancer
Experience
Senior CRA
Abeona Therapeutics
United States
CRA
Healthcare
United States
Senior CRA
kps life
Malvern, Pennsylvania, United States
Contract ended
Senior CRA
kps life
Malvern, Pennsylvania, United States
contract ended
Senior CRA
kps life
Malvern, Pennsylvania, United States
Global Oncology studies.
Senior CRA
PRA-ICON
United States
Sr. CRA
IQVIA Biotech
Morrisville, NC
Hematology trials in AML and MDS in TX, IL, FL, GA, TN, MI, OH, MD, NY, NJ and Toronto, Canada
CRA II
PRA Health Sciences
Tampa/St. Petersburg, Florida Area
Oncology clinical trials in FL, VA, MI, OK, IN, TX, KS, GA and TN.
CRA
inVentiv Health Commercial
Tampa/St. Petersburg, Florida Area
Oncology Clinical Trials in both FL and NC.
CTL Clinical Team Lead
DM Clinical Research
Spring, TX
Managing 14 Clinical studies with 7 employees and 1 phlebotomist in a FP clinic. Indications included: Flu vaccine for >65 years old population, Gout, DM, DM with Asthma, Hyperlipidemia, Observational studies and more. Interacted with CRO and monitors to ensure accurate data entry and patient compliance. QA of clinical data and trained new staff on studies. Drug accountability and storage.
CRC/Monitoring/Data Management
University of Miami
Miami, FL
CRC/Monitoring/Data Management Responsibilities: Monitored retrospective/current data for study compliance and additional preparation for all audits with creation of AE Logs, Con-Med Logs and Protocol Deviations, IRB submissions, Sponsor submissions. Successfully project manage 16 Oncology (GI/GU and Melanoma) Clinical Trials simultaneously : Phases I; recruitment/enrollment/compliance/data entry Scheduling and data capture for eCRF. Reviewed new studies to determine content accuracy and feasibility Prepared documents for presentation to various committees prior to approval Assured accuracy and consistency of research data between source documents and data entry Developed forms to summarize data, designed patient friendly dosage charts and compliance diaries Reviewed IIT Protocols for grammar, clarity and new information ( ICF, HIPAA and UChart language) Authored, Developed and Implemented an SOP for "The Maintenance of a Clinical Research Chart" Submissions of all Regulatory documents, with proper, timely reporting of AE/SAE, CRR and Annual reports to Regulating Agencies.
Clinical Research Associate
Advanced Clinical Services
1700+ subject Breast Imaging Study looking for a new indication; Monitored and Managed three ( 3) local sites and another site in SW Florida Monitored data entries and issued queries for responses, with a low incidence of protocol deviations along with meeting or exceeding sponsor deadlines and enrollment objectives. Developed Quality Assurance Guidelines, Drafted and Implemented Policies and Procedures for:"Completion of CRF's" and "Consenting "after identifying deficiencies. Extensive training, coaching and management of non-clinical staff (6) in CRF completion, GCP Guidelines and FDA Regulations. Verified subject enrollment/study compliance in terms of adherence to FDA Regulations and ICH/GCP Guidelines. Troubleshooting for equipment malfunctions and software issues, which eliminated the use of Tech. Support.
Education
Texas A&M University
Health Education/Community Methodology
Internship in Texas Dept of Mental Health Services of 6 months
Central Michigan University
Health/Health Care Administration/Management
Robin Hutchens's Contact Information
Phone
Find the Right Leads
Find Verified Contact Data
What LeadContact does well
Find verified emails, phone numbers, and decision-makers with 98% accuracy.
Find Leads
Find the right people by company, role, industry, location, and more.
925M+ professional profiles
Find Emails
Access verified email addresses for your target contacts.
657M+ emails
Find Phone Numbers
Get cross-validated phone data from multiple top sources.
239M+ phone numbers
More Accurate. Lower Cost.
Find contact data in 1 tool with 98% accuracy
LeadContact integrates leading enrichment tools to deliver more accurate contact data—without paying for each one.
Great conversations start with the right contact.
It’s time to find yours.