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Clinical Research Manager

Location:
Bronx, NY
Posted:
March 04, 2019

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Resume:

KARLAH MISIR

*** **** ***** ******

BRONX, NEW YORK, 10458

718-***-**** (HOME)

347-***-**** (CELL)

EMAIL: ac8n56@r.postjobfree.com

Education:

Fordham University, New York, NY, BA, 1997

Georgetown University School of Nursing, Washington, DC, Developing Clinical Research Associates Skills, May 2001

Bronx Community School of Nursing, Bronx, NY, 2003

Therapeutic Areas:

Oncology: Breast, Prostate, MDS, Ovarian, Renal, Lung, Melanoma, Head and Neck, Kidney,

Colorectal, Lymphoma, COPD, MS, Waldenstrom

Skills:

Microsoft Office 2003, Outlook, Arise, Concur, Medra, EDC/Medidata, eClinical, eTrack, Oracle

Clinical, CDSS, ClinAdmin, MIDB, Stars, Inform, Impact, MIDB

Career History

Sept 2015 July 2018 McGinnis Group/Celldex (contract)

A phase II melanoma study

Conducted:

Pre study visits

Initiation visits

Monitoring visits

Close out visits

Regulatory Review

Investigational Product

Data capture EDC

Report writing CTMS

SAE Reporting Requirements

December 2013 -August 2015 Aerotek (Contract)

Senior Clinical Research Associates-

Phase II Clinical trial on Waldenstrom disease

Monitored 49 patients

Data Capture (Inform), SAE reporting requirement, drug storage and accountability procedures

SAE Reporting Requirements

January 2011- November 2013, RPS

Senior Clinical Research Associates

Phases: I, III and Long term Follow-up-in patients with MS

Conduct pre-study, site initiation, monitoring, and final closeout study site visits

Data Capture (EDC), SAE reporting requirements, and drug storage and accountability procedures

Maintain records to ensure adequate documentation of the monitoring of each assigned clinical protocol

Ensure compliance with all applicable federal regulations, Good Clinical practice guidelines and standard operating procedures

April 2006- January 2011

Quintiles Senior Clinical Site Manager on Assignment for Amgen

Conducting pre-study, initiation visits for phase 1 clinical trial in COPD

Monitored phase II and III Oncology (Breast, MDS, Ovarian, Renal, Lung, Head and Neck, Kidney, Colorectal, Lymphoma) clinical trials

Conduct pre-study, site initiation, monitoring, and final closeout study site visits

Trained study staff on protocol, regulatory requirements, completing CRF’s, Electronic Data Capture (EDC), SAE reporting requirements, and drug storage and accountability procedures.

Maintain records to ensure adequate documentation of the monitoring of each assigned clinical protocol

Monitor study enrollment and protocol compliance

Ensure compliance with all applicable federal regulations, Good Clinical practice guidelines and standard operating procedures

Complete in-house monitoring activities as appropriate, such as updating in-house site files, and completing visit reports, and updating CDSS

Performed clinical trial initiation, monitoring and closeout activities while adhering to all applicable regulatory and standard Operating Procedures.

Conducted data query resolution and SAE information collection via

Facsimile, mail and telephone.



Contact this candidate