Ronald “Hawk” Hawkins

Phoenix, Arizona ***** 480-***-**** ad4u6l@r.postjobfree.com

U.S. Navy Veteran Graduate in American Indian Studies History, Magna Cum Laude Arizona State University graduate, focuses on philanthropy, ethical practice, and exceptional patient care in the medical field. With over 20 years of experience in ophthalmology, I have learned essential skills and vast knowledge within the field. Within the last 5 years, Research has become a special interest for me, and I plan to seek further education in the field of research.

Skills

Team Player

Engaged and Focused Learner

Building Strong Physician Relationships

Multi-Project Organization and Management

CITI GCP Social and Behavioral research

Pharma Engine

RAVE

Central Labs

Zelta EDC

IATA certified

Good Clinical Practice Certified (GCP)

CPR Certified

Study coordinator

CITI GCP Clinical Trial with Investigational Drug and Medical

Veeva Vault CTMS

Oracle Inform

JUDI system

Imedata EDC

HIPAA Compliant for Medical Setting

Electronic Medical Records

Electronic Data Capture System Entry (EDC)

Phase I-IV Trial Experience

Protocol Compliance

CITI Biomedical Research

Firecrest

Medidata

Veeva CTMS

Alpha/Sterling/CIRBI IRB

Professional Experience

Cornea and Cataract Consultants of Arizona Phoenix, AZ

Clinical Research Site Manager/ Clinical Study Coordinator (5/2023-present)

IQVIA Pharmaceutical Company San Diego, CA

Clinical Research Associate 2 (09/2022-12/2022)

Clinical Research Associate (Medasource Contracted-COMMON SPIRIT) BNI CRO Phoenix, AZ

Clinical Research Associate (11/2021-09/2022)

Clinical Research Consortium/ Allied Multispecialty Research Tempe, AZ

Clinical Research Coordinator (11/2020 – 10/2021)

RETINAL CONSULTANTS OF ARIZONA LTD/RETINAL RESEARCH INSTITUTE LLC Phoenix, AZ

Clinical Research Coordinator (05/2017-11/2020) Certified Ophthalmic Assistant (1998-05/17)

Cornea and Cataract Consultants of Arizona 3815 E. Bell Rd. #2500, Phoenix, AZ 85032

Maintaining up-to-date regulatory documents including site start-up, and Independent Review documents, as well as obtaining and maintaining up-to-date Curriculum Vitae, MICA, and licensing for all site investigators and study staff

Responsible for renewing and submitting Continuing Review form to the IRB.

Training of investigators and staff not present at Investigator Meetings or Site Initiation Visit in proper study protocol and execution to ensure accuracy of data and maintenance of study blind.

Initial reporting and update of Serious Adverse Events to IRB and study sponsors promptly to ensure subject safety.

Processing of lab specimens for accurate Immunogenicity and Pharmacokinetic results in multiple studies

Responsible for working up study patients: collecting medical history, vision examination, intraocular pressure, manual trial refraction, external slit lamp exams, scribing, and dilation.

Follow GCP and Human Subject procedures for trials in enrolling and ongoing studies

Responsible for managing the research department.

IQVIA Pharmaceutical Company 10188 Telesis Ct #400, San Diego, CA 92121

Responsible for clinical monitoring activities and overall project administration to oversee the progress of multi-center, investigator-initiated, or industry-sponsored clinical studies throughout the western United States.

Responsible for all site management and trial administration aspects as prescribed in the monitoring plans, and protocol and as directed by the Program Manager.

Verify study participants by confirming informed consent and protocol procedures have been performed in accordance with applicable regulations.

Responsible for working with sites providing ongoing training, remote monitoring, and interim field monitoring and close-out visits.

Evaluate onsite and remote monitoring activities such as the following: clinical data documentation, regulatory document review, monitor safety, and conduct of a study to ensure investigator and site compliance with the study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRA SOPs, and HIPAA guidelines.

Work cooperatively with the study team and operation management to proactively accomplish the project objective.

Proactively participate in CRA program development. This includes contributing to the overall quality improvement of clinical monitoring service and actively collaborating with program leadership to expand and grow the CRA’s professional portfolio.

Responsible for internal quality control process for assigned monitoring activities and contributed to improving and adapting quality control procedure. Align service goals with internal and external client expectations.

Responsible for timely reporting of all monitoring visit findings, completing comprehensive monitoring reports and associated deliverables to the Sponsor and the clinical sites.

Responsible for managing all monitoring visit travel arrangements and travel expense reporting activities in accordance with Quintiles travel and expense purchasing policy.

Barrow Neurological Institute Clinical Research Organization 240 West Thomas Road Phoenix, AZ 85013

Responsible for clinical monitoring activities and overall project administration to oversee the progress of multi-center, investigator-initiated, or industry-sponsored clinical studies throughout the United States.

Responsible for all site management and trial administration aspects as prescribed in the monitoring plans and as directed by the Program Manager.

Responsible for working with sites providing ongoing training, remote monitoring, and interim field monitoring and close-out visits.

Evaluate clinical data documentation, regulatory document review, monitor safety, and conduct a study to ensure investigator and site compliance with the study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRO SOPs, and HIPPA guidelines.

Work cooperatively with the study team and operation management to proactively accomplish project objectives.

Proactively participate in BNI CRO program development. This includes contributing to the overall quality improvement of clinical monitoring service and actively collaborating with program leadership to expand and grow the CRO’s professional portfolio.

Responsible for internal quality control process for assigned monitoring activities and contributed to improving and adapting quality control procedure. Align service goals with internal and external client expectations.

Responsible for timely reporting of all monitoring visit findings, completing comprehensive monitoring reports and associated deliverables to the Sponsor and the clinical sites.

Responsible for managing all monitoring visit travel arrangements and travel expense reporting activities in accordance with Dignity Health’s travel and expense purchasing policy.

Clinical Research Consortium/ Allied Multispecialty Research Tempe, AZ

Initiating/managing studies, and delegating responsibilities on the Delegation log of Authority per protocol.

Maintain up-to-date regulatory documents including site start-up and Independent Review documents, as well as obtaining and maintaining up-to-date Curriculum Vitae and licensing for all site investigators and study staff

Training of investigators and staff not present at Investigator Meetings or Site Initiation Visit in proper study protocol and execution to ensure accuracy of data and maintenance of study blind.

Initial reporting and update of Serious Adverse Events to IRB and study sponsors in a timely manner to ensure subject safety.

Processing of lab specimens for accurate Immunogenicity and Pharmacokinetic results in multiple studies

Responsible for all clinics to work up patients: phlebotomy, collecting medical history, and concomitant medications

Follow GCP and Human Subject procedures for trials in enrolling and ongoing studies.

RETINAL CONSULTANTS OF ARIZONA LTD/RETINAL RESEARCH INSTITUTE LLC Phoenix, AZ

Maintain up-to-date regulatory documents including site start-up and Independent Review documents, as well as obtaining and maintaining up-to-date Curriculum Vitae and licensing for all site investigators and study staff

Training of investigators and staff not present at Investigator Meetings or Site Initiation Visit in proper study protocol and execution to ensure accuracy of data and maintenance of study blind.

Initial reporting and update of Serious Adverse Events to IRB and study sponsors in a timely manner to ensure subject safety.

Processing of lab specimens for accurate Immunogenicity and Pharmacokinetic results in multiple studies

Responsible for all occasional assistance in the clinic to work up patients: collecting medical history, vision examination, intraocular pressure, Amsler grid testing, external ocular motility testing, confrontational fields, and dilation.

Assist as needed with intra-ocular injections and minor surgical procedures.

Follow GCP and Human Subject procedures for trials in enrolling and ongoing studies

Education

Arizona State University (2009) Bachelor of Science: American Indian Studies Magna Cum Laude, American Indian Studies Achievement Honors, Director’s List 2008, Dean’s List 2007

San Diego Community College (2001) Associate of Arts: General Studies

Mesa Community College (2017) Anatomy and Physiology/Medical Terminology

Arizona State University (2023)/ Currently attending graduate school for Clinical Research Master's Degree in Clinical Research Management with an emphasis in scientific regulatory.

Honors

Feller Award (2015) Patient Service Excellence

U.S. Navy/Marine Veterans (2002) Customer Service Award

Spectrum Award, Southern California (2002) Customer Satisfaction

US Navy (1998) Honorable Discharge

Community Service

Phoenix Rescue Easter Mission Event 2022

Veterans Missing In American Project 2021

Phoenix Rescue Easter Mission Event 2021

Phoenix Rescue Mission Support Center 2019

Phoenix Rescue Mission Support Center2013

White Mountain Apache Elders Health Program 2011

Hopi Special Diabetes Program 2010

Pueblo of Zuni Elders Day 2010

San Carlos Apache Elders Day 2010

Intertribal of Arizona Dental Sealant Program 2009

Tijuana Children Christmas Toys Benefit 1999

Acapulco Health Support U.S. Navy

Whiteriver Indian Hospital 1994

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