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Manager Clinical Research

Location:
Toronto, ON, Canada
Posted:
June 29, 2015

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Resume:

Skeeta Sobrian-Couroux

**** ******** *****, ***********, *******.

Email: acqhpm@r.postjobfree.com

Telephone: 1-647-***-****

SKILLS

Quantitative and qualitative research methodologies, operations and statistical analytical software.

Quality Improvement methodologies, International Organization for Standardization (ISO), LEAN and Six Sigma. Change transformation, dissemination and sustainability strategies.

Excellent interpersonal communication and presentation skills.

Collaborate in a diverse team environment.

Meticulous attention to detail and adaptable in a fast-paced working environment.

Engage, update and maintain stakeholder interest.

PROFESSIONAL ASSOCIATION ACCREDITATION

Canadian College of Health Leaders

College of Nurses of Ontario

Society of Clinical Research Associates

National Institutes of Health – US Department of Health & Human Services

Good Clinical Practice – Collaborative Institutional Training Initiative

Health Canada Division 5 – Collaborative Institutional Training Initiative

Ethical Conduct for Research Involving Humans (TCPS 2: CORE) – Tri-Council Policy Statement

WORK EXPERIENCE

Healthcare Consultant – Research and Quality Evaluations Jan 2015 – Present

ReQuE

Facilitate access to healthcare through research and quality improvement initiatives.

Provide start-up, education and training, ongoing monitoring and sustainability support for researchers and healthcare facilities undertaking initiatives with the goal to improve quality of healthcare.

Emphasis on long-term planning, implementation and sustainability of assessments and research to support best practices.

Services supported include clinical trials and quality improvement initiatives.

Senior Project Analyst – Process Improvement & Design Feb 2015 – April 2015

Halton Healthcare Services - 700 Dorval Street, Oakville, Ontario

Lead and complete the waitlist centralization project by defining scope and impact, measuring/collecting process data, analyzing findings and potential future processes and planning/implementing process improvements and control.

Act as a resource in the application of Lean/Six Sigma methodology, including process measurement and analysis, and process improvement identification, planning, execution and control.

Work with the management team to develop effective frameworks to assist operations, continuous quality improvement, and accountability.

Develop and implement a communication strategy for each area in support of basic principles of staff engagement, promotion, celebration and transparency.

Identify different levels of staff motivation and develop suitable strategies to encourage engagement.

Collaborate with external vendor to facilitate process design and improvement.

Research Manager – General & Trauma Surgery Programs April 2014 – Jan 2015

Sunnybrook Health Sciences Centre - 2075 Bayview Avenue, Toronto, Ontario

Oversee patient safety projects through research, quality improvement methodologies, and best practices.

Recruit, train and manage staff of 10 – 14 comprised of Research Coordinator and Research Assistants.

Oversee and ensure adherence to protocol, regulatory agencies and projected timelines.

Systematic literature reviews to support investigator initiated research and best practices.

Plan, develop, execute and publication input of pharmaceutical and investigator initiated studies.

Develop patient information materials and research recruitment tools.

Manage study budgets and facilitate grant application.

Develop training and evaluation measures for research projects, simulation and debriefing.

Collaborate with multidisciplinary groups and external facilities to accomplish objectives.

Develop, initiate, measure and monitor continuous quality improvement projects utilizing LEAN and Six Sigma methodologies such as Root Cause Analysis (RCA), Failure Mode & Effect Analysis (FMEA), Plan-Do-Study-Act (PDSA) cycles and Define-Measure-Analyze-Improve-Control (DMAIC) approaches.

Utilize Four Disciplines of Execution (4DX) principles to accomplish long-term sustainability.

Clinical Research Team Lead – Trauma Program August 2012 – March 2014

Sunnybrook Health Sciences Centre - 2075 Bayview Avenue, Toronto, Ontario

Plan, develop, execute and co-ordinate assigned clinical studies.

Coach and manage 24/7 Research Assistant team.

Oversee clinical trials to ensure adherence to protocol, regulatory agencies and projected timelines.

Assist in screening and recruiting of patients, when required.

Review documentation to ensure accurate data collection and data entry

Identify potential staff training needs and assist in training development of multidisciplinary trauma team.

Update the Research Manager and investigator of trial progress.

Work with the study team to maintain the objectives of the clinical trial.

Actively participate in the Research Journal Club meetings.

Operations Manager August 2011 – August 2012

Clinic Nurse (casual): November 2004 – August 2012

Mississauga Travel Clinic - 229A-5100 Erin Mills Parkway, Mississauga, Ontario

Liaise with site clinic manager to ensure OHIP billing, training and availability of front line staff.

Devise strategy to follow patients who require serial vaccination to promote repeat business.

Develop business plan to promote the clinic and implement initiative to increase the business potential.

Develop procedures based on Best Practices.

Primary care of current clients to foster follow up business.

Clinical Research Nurse Coordinator III April 2006 – July 2011

Princess Margaret Hospital

610 University Avenue, Toronto, Ontario.

Project management activities involved in study feasibility, budgets and target timelines

Complete all study procedures from initiation to study close as outlined in protocol.

Lead the trial and provide protocol specific training to staff, as well as training and mentoring new staff within the leukemia group.

Develop Case Report Forms, coordinate the collection of data with the Data Coordinator, analyze and communicate information from data sources.

Assist in the development of standardized documentation templates and Standard Operating Procedures.

Assist in application for Health Canada Special Access Drug, Ontario Excepted Access Program, and accessing financial drug coverage for patients through the Trillium Drug Program.

Clinical Research Team Lead February 2005 – March 2006

Ventena Clinical Research - 720 King Street West, Toronto, Ontario

Lead study teams comprising of nurses, Clinical Trials Assistants, and paramedics in the execution of early stage CNS pharmaceutical research specific to abuse liability.

Coordinate clinical trial in collaboration with sponsor, project managers, and external lab personnel.

Train all staff involved in the study as well as ensuring the integrity of the data being captured.

Assist recruiters in developing recruiting material such as advertising and screening questionnaires.

Oversee Research Assistants in the collection of research data and quality control reviews.

Clinical Research Nurse / Team Lead February 2003 – December 2004

Allied Research International - 4520 Dixie Road, Mississauga, Ontario.

Lead a team of Clinical Trial Coordinators and Clinical Trial Assistants in conducting single center environmental exposure chamber trials with up to 1200 subjects.

Execute study specific training and staff schedules to cover study specific duration.

Develop and update Standard Operating Procedures, training junior staff on basic assessments such as vital signs, allergy scratch skin test and multi-test trays.

Assist recruiters in developing recruiting material such as advertising and screening questionnaires.

Nurse January 2000 – December 2002

Sunnybrook Health Sciences Centre

Holland Orthopaedic & Arthritic Centre – 43 Wellesley Street East, Toronto, Ontario.

Primary care for post-operative patients.

Receive patients from operating room and provide post-anesthesia care.

Develop individual patient care plan with physician.

Collaborate with physiotherapist, social worker and personal support worker in the execution of daily patient care.

Ensure daily laboratory reports are available, reviewed, physician notified of any significant clinical values and anti-coagulation medications adjusted as required.

Clinical Research Associate January 1995 – January 2000

SmithKline Beecham - 2030 Bristol Circle, Oakville, Ontario.

Coordinate multi-center vaccine and anti-infective trials.

Manage and support sites in the execution of trials from start-up to study termination.

Track regulatory documents for each trial site as well as patient recruitment.

Conduct site selection visits and ongoing monitoring visits to review source and CRF documentation, drug compliance, and safety reports.

Assist in the development of vaccine Standard Operating Procedures after corporate merger.

EDUCATION

Masters of Science (Healthcare Quality) – Current

Queens University, Kingston, Ontario, Canada

Bachelor of Health Administration (Honors)

Ryerson University, Toronto, Ontario, Canada

Nursing Diploma

George Brown College, Toronto, Ontario, Canada

Human Resources Management Diploma

George Brown College, Toronto, Ontario, Canada

VOLUNTEER EXPERIENCE

Preceptor June 2014 – Present

School of Health Services Management - Ryerson University, Toronto, Ontario.

Fund Administrator May 2010 – August 2011

Ida Rubinoff Fund - Princess Margaret Hospital, Toronto, Ontario.

CONTINUING EDUCATION / WORKSHOPS

August 2012 (SoCRA)

Harnessing Social Media to Advance Clinical Research

September 2012 (Saf-T-Pak)

Dangerous Goods Shipping & Handling: Category A Infectious Substances, Category B Infectious Substances, Exempt Human and Animal Specimens, Genetically Modified (Micro) Organisms, Dry Ice, Dry and Wet Liquid Nitrogen Shippers, Excepted Quantities, Limited Quantities.

September 2009 (SoCRA)

Advanced Site Management: Finance and Productivity Enhanced Business Practices for Clinical Research Programs.

April 2007 (SoCRA)

Clinical Site Coordinator/Manager Program - GCP for Coordinators, Research Associates, Study Nurses, and Site Managers.

PUBLICATIONS / RESENTATIONS

Sobrian-Couroux S, McFarlan A, Rizoli S. Assessing the factors that affect ‘time to CT Scan’ and the effect on outcomes in moderate to severe Traumatic Brain Injury (TBI). Can J Surg. 2014 June; 57(Suppl 3):S53

Oral Presentation: Time to CT Scan in Traumatic Brain Injury in a Level 1 Trauma Center.

- Trauma Association of Canada (TAC), April 2014.

Poster & Oral Presentation: Good Clinical Practice (GCP) Knowledge Retention Among Research Assistants.

- Society of Clinical Research Professionals (SoCRA), September 2014.

Collaboration: Holcomb JB, Tilley BC, Baraniuk S, et al. Transfusion of Plasma, Platelets, and Red Blood Cells in a 1:1:1 vs a 1:1:2 Ratio and Mortality in Patients With Severe Trauma: The PROPPR Randomized Clinical Trial. JAMA. 2015;313(5):471-482. doi:10.1001/jama.2015.12.



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