Kelly Cairns
Burlington,Canada
Summary
Hard-working professional with exceptional experience leading teams, delivering results and exceeding expectations. Creative and motivated leader adept at utilizing exceptional design and planning strengths to accomplish complex projects. Skilled in teaching new concepts and best practice strategies. Highly effective and knowledgeable in process improvement and quality management.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Leader, Clinical and Business Operations
Boehringer Ingelheim Canada
11.2010 - Current
- Oversight of Business Operations, Vendor Partnerships, Investigational Supplies and Business Support teams
- Active leadership role in strategic discussions and initiatives that improve clinical trial and business strategy; ensure processes are in place to ensure delivery of quality; to achieve fiscal soundness of all internal/external aspects of Clinical Operations and that trials are delivered on time and on budget
- Responsible for ensuring that all trials are appropriately resourced, developing strategies to maximize efficiencies/effectiveness of unit which includes both internal and external (e.g. insourced/outsourced) team members
- Active in Quality Management for Clinical Development & Operations in Global Quality Network and CAPA lead communities
- Ensure trial activities are carried out in full compliance with corporate SOPs, local Working Instructions and Health Canada Regulations
- Leadership of Business Support Team with effective oversight of clinical trial contracting and budget management responsibilities
- Evaluate employee performance, coach and train to improve inefficiencies/weak areas while maintaining team flexibility and ability to adapt to changing environment
Manager, Investigational Supplies
Boehringer Ingelheim Canada
07.2007 - 11.2010
- Manage performance and development of the investigational supplies team through hiring, orientation, development, performance management, productivity and metrics
- Cross-trained existing employees to maximize team agility and performance
- Participate and provide input in working group meetings to ensure IS requirements including packaging, quantity and specific storage/handling are met for local study initiations
- Maintain accurate and controlled levels of investigational supply inventory through ongoing planning and projection for current and future trials
- Provide ongoing training to Clinical Trial Teams and Clinical Trial Sites for Investigational Product.
Senior Research Associate
Boehringer Ingelheim Canada
01.2005 - 07.2007
- Clinical project management of local clinical study progress during initiation, conduction and report phase
- Ensure study protocol and related documents are available for study initiation; identify and select investigators; calculate timelines and resources for local use; leadership and management of local trial teams and working groups; conduct investigator training meetings and conduct CRA training sessions; monitor local trial progress to ensure that global clinical recruitment timelines are met; review data discrepancies and participate in data quality reviews; ensure all safety reporting is done in a timely manner
- Ensure high quality and timeliness of clinical trial and final study report by supervising CRO and/or CRA activities, reviewing ongoing safety data, assuring study is conducted according to local and international standards and SOPs
- Mentor and train Research Associate (RA) group members regarding their role in key clinical research processes
Education
Master of Arts - Leadership
University of Guelph
Guelph, ON02.2011
Bachelor of Applied Science -
University of Guelph
Guelph, ON04.1982
Leadership in Action Training Program
Effective Communication For Partnership Workshop Series
09.2008
The Project Management Course
06.2006
Clinical Research
CCRA Certification
03.2001
Accreditation -
APMR Accreditation
11.2000
Skills
- Strategic thinking
- Continuous improvement mindset
- Recruitment and hiring expertise
- Quality focus
- Fiduciary responsibility
Activities
- ACRP, Fellows Advisory Panel member, 2022 to present
- ACRP, Fellow of the Association of Clinical Research Professionals (FACRP), 2018 to present
- ACRP, Executive Director Search Committee, 2015
- ACRP Academy Board of Trustees, Immediate Past Chair, 2020
- ACRP Academy Board of Trustees, Chair, 2017 to 2019
- ACRP Academy Board of Trustees, Vice Chair, 2015 to 2016
- ACRP Academy Board of Trustees, 2012 to 2014
- ACRP CRA Certification Exam Committee, Global Immediate Past Chair, 2011
- ACRP CRA Certification Exam Committee, Global Chair, 2009 to 2010
- ACRP CRA Certification Exam Committee, North American Chair, 2007 to 2008
- ACRP CRA Certification Exam Committee, 2005 to 2007
- ACRP CRA Certification Exam, Item Writing Sub-Committee, 2002 to 2005
- ACRP CRA Forum Steering Committee, 2003 to 2007
- ACRP Canadian Chapter, 2001 to present
Publications
OPINION: The Role of Certification in Developing a Quality Clinical Workforce, Clinical Researcher, October 2017, Cairns, K.
2005 CRA Salary Survey, The Monitor, Winter Issue 2005, Craig, K., et al
2004 CRA Salary Survey, The Monitor, Spring Issue 2005, Cataruozolo, P., et al
2003 CRA Salary Survey, The Monitor, Spring Issue 2004, Cataruozolo, P., et al
IND Safety Reporting In Megatrials: Is There A Better Way?, ACRP ANACE Poster Presentation, 2003, Kelly Craig, BASc, APMR, CCRA, Chris Slack, MSc.
ICH Guidelines vs. FDA Regulations: What Does This Mean to Conducting Canadian Clinical Trials?, ACRP ANACE Poster Presentation, 2002, Marianne Jaszek, APMR, CCRA, Kelly Craig, BASc, APMR, CCRA, Chris Slack, MSc.
Affiliations
Association of Clinical Research Professionals
Certification
- Certified Clinical Research Associate (CCRA)
- Fellow of the Association of Clinical Research Professionals (FACRP)
- Accredited by the Pharmaceutical Manufacturers Association (APMR)
Passion for dog rescue
Active volunteer involvement with TEAM Dog Rescue, a volunteer run, foster based rescue. Have held the role of Volunteer Manager since 2018 and have been on the Board of Directors since January of 2023. Have gained valuable experience in the leadership of a charitable organization.
Timeline
Leader, Clinical and Business Operations
Boehringer Ingelheim Canada
11.2010 - Current
Manager, Investigational Supplies
Boehringer Ingelheim Canada
07.2007 - 11.2010
Senior Research Associate
Boehringer Ingelheim Canada
01.2005 - 07.2007
Master of Arts - Leadership
University of Guelph
Bachelor of Applied Science -
University of Guelph
Leadership in Action Training Program
Effective Communication For Partnership Workshop Series
The Project Management Course
Clinical Research
CCRA Certification
Accreditation -
APMR Accreditation
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