Karen Fraser

Director of Clinical Operations @ Clinlogix, Now Part of NAMSA

About

Professional Summary and Experience: A results-oriented professional with experience in global clinical trial operations and a bachelor of science in nursing from Emory University and a Masters in Healthcare Administration from Mercer University. Uniquely experienced and knowledgeable in the areas of both post market trials as well as IDE/PMA pre-market studies for both start-ups and mid-sized companies. Drug/device combination products. Regulatory intelligence, strategy and operations excellence; hands-on, practical approach. Background includes the management of existing budget and staff as well as forming entire US and international clinical departments. Technical expertise is coupled with excellence in staff development, strategic project oversight, and program and budget management. Specialties: clinical strategy development, budget management, business intelligence, database administration, study operation, IDE execution, leadership, contract negotiation, nursing, project management, protocols, report and publication development, staff development, supervisory skills, physician (KOL) and site relationship development and management, international regulations, Medical specialties: cardiac cath lab, heart failure, orthopedics, endovascular therapies, intensive care, women's health, peripheral artery disease, endovenous therapies, stroke, and combination products.

Country

United States

City

Fort Pierce

Industry

Medical Device

Skill

Start-ups, Team Leadership, Combination Products, Program Management, Clinical Trial Implementation, Staff Supervision, Contract Research Organization, Clincal Strategy and Design, Problem Solving, Budget Management, Medical Devices, Clinical Trials, FDA, Clinical Research, Cardiology, Product Launch, Cross-functional Team Leadership, Healthcare, Management, Leadership

Experience

Director of Clinical Operations

Clinlogix, Now Part of NAMSA

2021-1 - 2021-9 · 9 mos

Vero Beach, Florida, United States

Sr. Project Manager

ICON plc (formerly MDCI, Medical Device Consultants, Inc.)

2016-11 - 2021-1 · 4 yrs 3 mos

Sr. Director, Clinical

VENITI, Inc.

2012-5 - 2016-1 · 3 yrs 9 mos

Greater St. Louis Area

Director of Clinical Affairs, Combination Products

Medrad

2008 - 2012-5 · 4 yrs

Minnepolis Minnesota

Responsible for the development, management, and implementation of MEDRAD’s Combination products clinical trials from inception through market approval. Also responsible for providing direction, management, mentoring and guidance to Clinical Program Managers, Clinical Research Associates (CRAs), Clinical Trial Coordinator (CTC).