*. Personal Information:
Place of Birth: Baton Rouge, Louisiana, US
Citizenship: USA
Addresses: (home)13357 Briar Hollow Drive
Baton Rouge, Louisiana 70810, US
(email) c53lf7@r.postjobfree.com
Phone: (smart phone) 225-***-****
2. Personal: 1 Child: Gabriel
3. Most Recent Position: Director, Division of Clinical Research
Director of STS Data Management
Research Student Liaison
Clinical Research Nurse Coordinator
Duties:
Budget and contract negotiation, study
procurement, regulatory submission and reporting to
local and national IRBs and other related regulatory
authorities, recruited and consented patients
according to the protocol, all clinic visits in
clinic and OR settings, collaboration with pharmacy,
OR staff, Surgical Staff, Surgical tech staff,
ultrasound technologists, and monitoring staff.
Insured FDA regulations were followed at all times,
wrote and supported the SOPs for the division.
4. Education: Rockhurst College/Research College of Nursing,
Kansas City, Missouri
Bachelor of Science, Nursing
Southeastern Louisiana University
Hammond, Louisiana
Bachelor of Arts, Business Management
5. Experience: Clinical Research Coordinator since 1998
Previous Employers:
Continence Consultants in St. Louis, MO
Specialty: Urology, Urodynamic Testing, 1997-1999,
test performance, results interpreted and presented
for medical record, advanced to clinical director for
the practice, began working with CROs in industry-
initiated trials.
Gateway Medical Research in St. Charles, MO
Specialty: Generic bioequivalence trials, 1999-2002
Co-supervised 60 employees, managed in-house studies,
prepared dosing, checked source documents, performed
QA functions, managed PI's for each trial, and worked
with CRO staff as needed as studies were monitored.
Kilo Clinical Research in Saint Louis, MO
Specialty: Endocrinology, 2002-2004
Performed functions of a clinical research
coordinator. Performed visits, blood work, blood
processing and shipment, scheduled appts with PI and
dietary specialist, performed pulmonary function
testing to capture data, screening medical exams and
testing, completed EDC and paper CRFs as needed,
accommodated CRA staff as monitors as needed for up
to 5 studies at once.
Washington University School of Medicine
Mallincrodt Radiology Research
Specialty: Radiology Research, 2005-2006
Initiated trials related to radiology research as
assigned by manager. Performed regulatory functions
and worked to get IRB approval and IBC approval for
several trials.
Additional Experience pre-research:
Registered Nurse since 1994
Experience in PACU, SICU, MICU, Med/Surg, Private
Duty and Cardiothoracic Surgery Office.
Additional Experience: Public Relations, Marketing,
Instructor, Anatomy and Physiology
6. Licensure: State of Missouri, Nursing License # 144492
State of Louisiana, License # RN077356
7. Memberships: Association of Clinical Research Professionals
Sigma Theta Tau Honor Society of Nursing
Since 1999
10. Certifications: Certified Clinical Research Coordinator,
Association of Clinical Research Professionals
Since 2006
Certified Research Contract Professional,
MAGI, Model Agreements & Guidelines International
Since 2007
11. Abilities: Experience working with Industry and NIH sponsored
clinical trials. Knowledge and understanding of
clinical trials regulatory guidelines and
requirements (OHRP, ICH, GCP and FDA), as well as
extensive experience with Microsoft and Mac.
Excellent interpersonal skills, strong oral and
written communication skills with experience in
conflict resolution and contract negotiation.
12. References Available upon request