Tevea Kem

Obj***

Obj***

***** **

Helen Ave,

Carson, CA

***** ****:

562-***-**** -

teveak@hotmail.

com

Professional Summary

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Objective: Seeking a position in Clinical Research with a globally focused organization,

which will utilize my qualifications, while offering new opportunities to integrate

personal enrichment and professional goals.

Skill Highlights

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● Ability to identify and resolve all issues ● Strong clinical background

● Ability to cooperate with all team members ● Data management

Strong communication

● Quick to learn ● skills

● HIPAA Regulations ● Management of staff

Relevant Experience

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Alzheimer’s Disease Diabetes Type I Diabetic Neuropathy

Major Depression Diabetes Type II Medical Devices

Schizoaffective Disorder Hyperlipidemia Renal Failure

Schizophrenia Hypertension Oncology (Multiple Myeloma)

Professional Experience

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Assistant Clinical Project Manager

Jan 2013 to May 2014

Criterium Inc CRO – Saratoga, NY (Home-based in LA)

• Participated in global study meetings with sites and sponsors.

• Management of SAE s, SAE Safety Review, and ISL s

• Managed/Trained Investigative research and ancillary hospital staff and

served as Primary Liaison between site and sponsors

• Coordinated with sponsor for all project deliverables within timeframe

• Review regulatory documents according to ICH/GCP guidelines and 21CFR

and also ensured SOP, FDA, ICH GCP regulatory compliance.

• Responsible for all phases of clinical trials, from feasibilities through to start-

up, monitoring and close-out

• Evaluated work for clinical projects. (ex: monitoring reports, EDC data etc)

Senior Clinical Research Coordinator

February 2011 to March 2012

CNS Network – Garden Grove, CA

• Primary Study Coordinator for the research site on 9 protocols simultaneously,

ensured the implementation of all study procedures per protocol assigned, and

served as regulatory coordinator on all assigned protocols.

• Submission of SAE's, Safety Reports, Protocol Deviation, Temperature

excursion, IRB acknowledgment, and most required IRB forms.

• Coordination and implementation of protocols in compliance with GCP and

ICH Guidelines, assisted in drafting documents for several protocols, drafting of

enrollment logs and study medication logs for various protocols at site, and also

responsible for Electronic data entry for 8-10 protocols.

• Ensured the safety of study patients by following protocol and safety measures,

liaison between site, CRA and vendors.

• Responsible for oversight of all staff assigned to the 9 protocols.

• Monitored project activity and managed the project group.

• Evaluated work for clinical projects.

Senior Clinical Research Coordinator

March 2008 to February 2011

Diabetes/ Lipid Management & Research Center – Huntington Beach, CA

● Primary Study Coordinator and regulatory coordinator for the research site on 7

protocol, and ensured the implementation of all study procedures per protocol

assigned.

● Recording and review of AE, SAE and concomitant medications.

● Primary laboratory coordinator for all protocols on site (15-20 protocols).

● Responsible for management of clinical supplies for entire site including study

medication.

● Assisted in several medical device studies.

● Attended several Investigator meetings on behalf of site manager.

Social Workers Assistant

January 2007 to March 2008

Best of Times ADHC – Los Angeles, CA

● Patient Assessment such as mental assessments, psychological tests, and

questions, projects such as coordinating day events for participants, creating

group therapy sessions 1-3 times a week for participants, and conducting group

counseling for patients 2-3 times a week

● Maintained regulatory documents for project manager, responsible for

organization of participant charts, overseeing patient’s growth in the program

and help participants grow mentally.

Clinical Research Assistant

October 2005 to January 2006

Diabetes Research Center – Tustin, CA

● Assisted with study procedures

● Administrative office functions

● Assisting with various clinical study projects

Intern

April 2005 to June 2005

Allergan – Irvine, CA

● Assigned daily projects by the director of ophthalmology as well as work on

projects with the director of ophthalmology

● Track files and folders for CRA's review, FDA regulation guidelines with CRA's,

reviewing SAE's and AE's with CRA's, help organize payment files for CPA's,

● Attend meetings with the director of ophthalmology, Create files and charts,

data entry as assigned by director or CRA, and review ECRF entries from

participating sites with the CRA.

Education and Training

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University of California – Irvine, CA 2005

Social Ecology, Environmental Analysis, Sociology & Minor in Biological Sciences

B.A

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