Bojana Turic

Logistics & Clinical Multi-Site Operations

Clinical Trials Design & Development

l   Experience in conducting multi center international clinical trials.

l   Strong knowledge of biotechnology and Medical Device Industry

l   Held few corporate positions at Perceptronix Medical Inc.

l   Clinical and regulatory Led the company’s international clinical trials and regulatory application processes (Health Canada, EU, FDA, China FDA, Philippines, Malaysia and TFDA in Taiwan) including establishing quality management system : ISO 13845 and 9001

l   Operations – Organized clinical trial coordination, led training and monitoring of sites,

l   Launched first commercial activities and customer service support

PROFESSIONAL EXPERIENCE

Bojana Turic – Consulting                                     2015

Find, meet, track, rank and monitor a pipeline of prospective companies for

assessment of business strategies, value proposition, customer traction,

technology viability, market size, clinical and regulatory strategy

Aspect Biosystems                                      2014-2015

l   Advisor, Business Development, Clinical and Regulatory Affairs

l   Management consulting for the Company’s strategic plan and fundraising

l   Established regulatory and quality control pathway for the Company’s instruments

Perceptronix Medical Inc,

President and CEO                                        2007-2014

l   Overlooked all R&D studies sponsored by the Company

l   Actively managed all regulatory and quality processes for the Company (med device class I , II and III)

l   Established partnership with Northern Health Authority in BC for use of Perceptronix laboratory services

l   Lead the team that executed first sales and marketing initiative including several strategic partnerships with international laboratories

l   Actively managed regulatory approval process in China (CFDA)

l   Established MOU for sales with the biggest publicly traded laboratory (DIAN diagnostics) and medical device distributor (Tenry Pharmaceutical) in China.

COO                                                 2006-April 2007

Organized and led implementation of ISO quality management process ISO 13845 and 9001 which was passed with success Responsible for the oversight of clinical budgets and ensure clinical study timelines are met on time and within budget.

Led the Company’s laboratory accreditation process and quality control implementation

Organized company’s first commercial processes and initiatives

Developed sales and marketing initiative for penetration of diagnostic testing

VP, Director of Clinical and Regulatory Affairs                 2004-2006

l   Arranged and filed all company’s approval process and licenses (class I, II and III)

l   Successfully negotiated clinical trials protocols and results presentations at Health Canada, FDA

l   Overlooked technical file creation for EU approval process

l   Successfully obtained FDA product listings and permission to conduct clinical trials for fluorescence bronchoscopy trials (IND)

l   Implemented protocols and monitoring processes of multi-center international clinical trails

Director of Clinical Trials and Regulatory Affairs ,            2000–2004

l   Site identification/ Selection & Development for Clinical Studies and building of key relationships with health care professionals including (KOLs) while focusing on key business objectives

l   Created all clinical trial protocols and SOPs for main products

l   Trained each clinical trial site team and laboratory personnel

l   Acquired Ethics board approvals in record short time for each clinical trial site (8 international sites) Canada, USA, UK, Slovenia, Korea, Spain, Netherlands, Russia

l   Created integrated logistics during clinical trials from consolidating recruitment of patents, Visit Report (completion/review/submission), Query rates, Enrollment logs etc.

HealthQuest Comprehensive Ltd.

Clinical Research Associate                                1997-1999

Private clinic with the main focus on the addiction treatment and clinical trials

execution for Pharmaceutical Companies

l   Responsible for all aspects of conduct of research and clinical trials, from recruitment, blind treatment, to follow up visits until study closure

l   Achieved substantial bonus gain from Shearing Plough as a number one recruiting site

West Coast College of Massage Therapy,

Director of Academic Department and Academic Instructor,   1998-2000

Number one North America and International recognized college for providing an outstanding education in the regulated healthcare field of massage therapy

l   Organized efficient curriculum in neurology, statistics and research

l   Academic instructor for four major courses

l   Currently holds position as a member of Medical Advisory Board since 2003