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Manager/Coordinator of Clinical Research Department

Location:
Maryville, TN
Posted:
June 13, 2023

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Resume:

KIMBERLEE RIVERA

*** ******* **, *********, ** **803 865-***-**** adxoz1@r.postjobfree.com

Highly motivated and vastly experienced in clinical research, from budgeting contracts through close-out. I have been an effective manager of the research department for the past 10 years creating an excellent rapport with the sponsors and CROs. Well versed in reading protocols, maintaining timelines, scheduling windows and creating a productive work environment.

Experience

University Eye Specialists - 622 Smithview Dr. Maryville, TN 37803 (2007–current)

• Lead Clinical Research Coordinator

Excellent organizational/time management skills

Superior written and verbal communication skills

Proficient in MS Word, Powerpoint, Office, Excel

Manage entire research site

Excellent knowledge of GCP, ICH, FDA regulations

IRB approval/correspondence

Experienced in multiple EDC platforms, entry and query resolution

Create/complete CRFs and SOPs

Maintain associated documentation, record keeping, collection and organization of trial data

Knowledgeable in study start-up and close-out procedures

• Certified Ophthalmic Assistant

Refraction Specular Microscopy Imaging IOP measurement (Goldmann and Tonopen)

ETDRS Visual Acuity OCT Cirrus/pachymetry Humphrey Visual Field

Visucam IOL Master Keratometry

Education

Nova Southeastern University, Fort Lauderdale, FL

Bachelor of Science- Life Science

Broward Community College, Fort Lauderdale, FL

Paramedic Certificate

Certifications

Certified Ophthalmic Assistant

Clinical Trials Operations

Design and Conduct of Clinical Trials

Clinical Trials Data Management and Quality Assurance

Clinical Trials Management and Advanced Operations

Clinical Trials Analysis, Monitoring and Presentation

Sponsored Research

1. Protocol: TMI-09-1 Transcend Medical, 2012

2. Protocol: 769 Bausch & Lomb, 2013

3. Protocol: CP 11-001 Ivantis, INC., 2013

4. Protocol: OTX-13-002 Ocular Therapeutix, Inc., 2013

5. Protocol: PPL GLAU M1 Mati Therapeutics, INC., 2014

6. Protocol: FSV5-004 ForSight VISION 5, 2014

7. Protocol: FSV5-005 ForSight VISION 5, 2015

8. Protocol: AR-13324-CS304 Aerie Pharmaceuticals, Inc. 2016

9. Protocol: TMI-09-01-E Transcend Medical Inc. 2016

10. Protocol: IPC-02-2015 Inotek. 2016

11. Protocol: AR-13324-CS205 Aerie 2017

12. Protocol: GLD122e-P001 Alcon, 2018

13. Protocol: 011709IN Santen 2018

14. Protocol: 011712IN Santen 2019

15. Protocol: 188*-***-*** Allergan 2019

16. Protocol: MIM-728 Mimetogen Pharmaceuticals, 2019

17. Protocol: PRG-NY-19-001 Perrigo Pharma Int’l, 2019

18. Protocol: 06807 Site Sciences, Inc, 2020

19. Protocol: CECF843A2201 Novartis 2020

20. Protocol: 07024 Sight Sciences, Inc. 2020

21. Protocol: PRG-NY-20-002 Perrigo 2021

22. Protocol: GLD122-P004 Alcon 2021

23. Protocol: SAF312B12201 Novartis 2021

24. Protocol: DE-126 Santen 2021

25. Protocol: CLN1-07277 Sight Sciences, inc. 2021

26. Protocol: 07355 Sight Sciences, inc. 2021

27. Protocol: DF6-CL-21-02 New World Medical, 2021

28. Protocol: VT-003 Visus Therapeutics, Inc 2022

29. Protocol: AR-15512-LTSS Aerie 2022

30. Protocol: STN1013600 Santen Inc. 2022



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