Kenneth Clark

***** ******* ** #**** *******, CA 92584

acda8x@r.postjobfree.com

909-***-****

SUMMARY

Pharmacovigilance Clinical Research Associate/Coordinator II, with four (4)

years professional experience, working with Pre-trial to Phase IV studies.

Director of Health Information Management and Consultant.

PROFESSIONAL EXPERIENCE

Park West Care Center-Santa Ana, CA

01/12- 2-28-14

Health Information Supervisor

. Analysis and coding of medical records

. Abstract coding

. Supervise a staff of one

. Daily audits

. Supervise 1 staff member

. Staff training

. Data entry of T.O. admissions and Discharges

Vista Cove Care Center-Corona, CA

07/10 - 01/12

Health Information Supervisor

. Analysis and coding of medical records

. Abstract coding

. Supervise a staff of three

. Daily audits

. Staff training

. Data entry of T.O. admissions and Discharges

Colonial Care Center-Long Beach, CA

05/10-07/10

Health Information Supervisor

. Supervise a staff of three FTE

. Analysis and coding of medical records

. Data entry of admission and discharge patients

. Daily audits of the Sub-Acute unit

. Supervise three nursing station

. Staff training

. Weekly report to the administrator

CEDAR-SINAI MEDICAL CENTER - COLOPLAST PHARMACEUTICALS Beverly Hills, CA

8/08 - 1/09

Clinical Research Associate II / Consultant

. Handled patient inquiries and complaints in regards to their Medical

Device and collect accurate information to be provided to Health Care

Professional including doctors, nurses, etc

. Managed, registered and monitored reportable AE and SAE from the

devise study.

. Phase I-IV experience, which includes assisting in database testing

and locking.

. Pre-trial analysis, of new patient's enrollment for inform consent and

qualification for study.

. Queried site for additional information from the Medical Director

assistance on site.

. Quality assurance of the Access database for the correct data

information from three other DB.

. Register SAE/AE on the CRF and into the safety Data Base.

. Regulatory Affairs clinical study start up binders set up and audit

for completion.

. On sight Clinical Research Coordinator

. Reconciliation of SAE reports

VALEANT PHARMACEUTICALS - Mission Viejo, California

1/08 - 8/08

Safety Data Administrative Specialist / Pharmacovigilance Consultant

. Quality assurance of the AERS database for correct submission data

of the 15 day IND report to the FDA.

. Register SAE/AE reports into AERS database.

. Reconciliation of SAE reports

. Coding of the verbatim term of the SAE and AE in the Oracle AERS

database.

. Documentation of the procedure for submission of the 15 day IND report

to Regulatory Affairs for submission to the FDA.

. QC workflow from Pharmacovigilance to Regulatory Affairs of FDA

submission

. Audit of the FedEx tracking sheet for the correct date of 15 day

IND submission to FDA.

. Review of analysis during Weekly meeting with department directors.

. Weekly data report of submissions submitted for the Crystal report.

COMMUNITY CONVALESCENT HOSPITAL - Glendora, CA

7/07 - 1/08

Medical Records Auditor

. Assist the Medical Records Department with audits and review of

medical records

. In-service with the license nursing staff regarding correct chart

documentation

. Daily reports to the D.O.N. of the results from the medical records

chart review audits.

. In-service with the C.N.A. and the R.N.A. about documentations.

ODYSSEY HEALTHCARE Hospice - West Covina, CA

6/06 - 5/07

Admissions Coordinator

. Assistant with the directions of admission of patients to our

healthcare agency

. Provide assistant with clarification of orders and medical coverage

. Provide support with, information and in-services

A.S.A.P. STAFFING - Long Beach, CA

6/06 - 11/06

Quality Assurance Analysis / Medical Records Abstract Consultant

. Quality assurance audits of the in-patients records for accurate

documentation.

. Assembly and analysis of discharge patient's records.

. Daily audits of records of new patients admitted to the hospital.

CODE MED INC. - Los Angeles, CA

9/05 - Present

Health Information Management Consultant

. Analysis of patient records for completeness.

. In-house concurrent review of patients' charts for complete

documentation.

. Admission and discharge.

. Purging records, filing, ROI, Abstract

. Chart analysis.

. Month end report to the H.I.M. Supervisor.

QUINTILES TRANSNATIONAL - Morrisville, NC

9/02 - 8/05

Pharmacovigilance Clinical Safety Specialist II

. Managed and monitored reportable serious adverse events from the

drug or devise study.

. Phase I-IV experience, which includes assisting in database testing

and locking.

. Concurrent analysis of documentation emailed or fax to the site.

. Queried site for additional information.

. Coding of SAE using WhoDra and or MeDra database coding.

. Performed data entry into Argus, Clintrace, Clinical AERS and

Oracle safety databases.

. Performed Inform and the Phase4ward (live data) training for these

safety databases.

. Two years experience in CEVA.

. Supervised staff for investigator mailings.

. Coding of medications, devises and diagnosis. Lead CRA for 12

studies 10 of which were global.

. Received two awards for great customer service from Pfizer and

Alliex Pharmaceutical, Inc.

EISENHOWER HOSPITAL - Pasadena, CA

2/96 - 6/98 / 4/00 - 11/01

Director of Medical Records

. Managed the medical records department for 100-bed rehabilitation

hospital.

. Coding of diagnosis with the ICD-9

. Analysis of medical records daily

. Admission and discharge of patients

. Utilization review committee director

. MDS Coordinator/Submissions

ST. LUKE MEDICAL CENTER - Pasadena, CA

5/98 - 12/01

Hospital Records Analyst / Director of TCU Sub-Acute Medical Records

. Daily analysis of medical records for the acute patients.

. Admission and discharge of patients in the sub-acute & TCU unit.

. Coding of all diagnosis.

. Close chart utilization review committee. QA of records for JHACO.

. Monthly report submitted to the CFO, CNO and HIM supervisor

EDUCATION & TRAINING

Graduate of Promise Christian University Pasadena, CA

Doctorate in Religious Studies PhD.

8-17-2013

Belford University- (11/2006)

Master of Arts - Major: Religious Studies (Magna cum Laude)

Shaw University-Raleigh, North Carolina (03/2003)

Bachelor of Arts (03/2003) - Major: Religious Studies

Pasadena City College-Pasadena, CA (10/1991)

Course Study - Medical Insurance Billing/ICD-9 & CPT Coding

Big Bend Community College-Moses Lake, Washington (3/1979)

Course Study - Math and Communications

COMMUNITY INVOLVEMENT

. Volunteer - Gems Non-Profit organization, Scholarship Youth Program

. Youth & Family Counselor

. Pastor of Community Outreach

. L.I.F.E. Living In Faith Recovery Ministry Teacher

. Calvary Murrieta Christian School Varsity Girls Basketball Coach

AWARDS & CERTIFICATIONS

. Excellent Customer Service from Pfizer Pharmaceuticals, 2005

. Excellent Customer Service from NPS-Allelix Pharmaceuticals, 2004

. Certified Social Services Director for Long Term Care Residents,

1995

. Certified Nurse Aide, 1984.

. Ordained Minister 2009

. Certified Chaplin, 2008,

. Promise Christian University Certified Chaplains Training I, 3/2014

SPECIALTY SKILLS

. Supervision; ICD-9 & CPT coding

. MS Word /MS Access/Excel/MS Dos.

. Safety Database expert for the Argus, Inform, Oracle AERS, Live

Link;

. Clintrace Database. Special training for Phase4ward live captured

data.

. Pre/Post Clinical Trial Study. Phase I to IV Pharmacovigilance

experience.

. Excellent ICH, GCP knowledge.

. Medical coding using MedDra and Whodra dictionary for AE/SAE.

. Coding of Medication in the safety database.

. CPR/First Aid Certification 3/2014

REFERENCES

Will be made available upon request

Contact this candidate