Jan Burd
Auckland
Summary
A senior clinical research professional experienced at managing pharmaceutical and medical device clinical trials. Demonstrated broad experience across the clinical research environment as both a Senior Clinical Research Associate and Senior Study Coordinator. An extensive background as a healthcare professional. A detail-oriented team player with excellent organizational skills and a strong ability to handle multiple projects simultaneously with a high degree of accuracy. Seeking a senior research role where these skills and experience can contribute to the ongoing success of the research team.
Overview
30
30
years of professional experience
Work History
Senior Clinical Research Associate
Green Lane Coordinating Centre Ltd
08.2020 - Current
- Conducted initiation, monitoring and closeout visits of clinical trial sites to verify study procedures, regulatory documents and data completion.
- Ensured the conduct of each trial was in compliance with currently approved clinical trial protocols, ICH/GCP, applicable Standard Operating Procedures (SOPs) and applicable regulatory requirements.
- Monitored clinical sites on regional and national level, providing leadership to less experienced site staff.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Built strong relationships with investigators and research teams.
- Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
- Participated in the development, organisation and delivery of Investigator Meetings, training sessions, and other events related to clinical studies.
- Developed study protocols, ICFs and case report forms for clinical trials.
- Prepared and submitted required documentation for New Zealand HDEC review and approval.
Senior Research Coordinator - Interventional - Cardiology
AUCKLAND CITY HOSPITAL
03.2008 - 08.2020
- Managed Interventional Cardiology research trials and projects, including design, initiation, recruitment and follow up for trials to standards that exceeded international best practice, HDEC requirements and regulatory requirements.
- Handled start-up work, including preparing and submitting HDEC and locality submissions for approval, developing study budgets and negotiating CTRA's.
- Managed multiple projects simultaneously, ensuring timely completion and high-quality results.
- Assisted in the development of informed consent documents for study participants.
- Prepared recruitment tools, protocol worksheets, procedural manuals and other study-related documentation.
- Ensured timely reporting of adverse events or safety concerns to regulatory authorities.
- Exceeded enrollment goals by development and executing proactive strategies focused on identifying participants.
- Organized and maintained complete records for each study, including case reports forms, source documentation and regulatory paperwork.
- Achieved repeated collaboration with sponsors over time due to consistent delivery of high quality research processes and outcomes.
- Developed a reputation within the industry as a knowledgeable, professional, effective researcher
- Published paper in the Journal of Cardiology
Senior Registered Nurse
MERCY HOSPITAL, EPSOM
08.2006 - 03.2008
- Participated in planning and delivery of pre and post-operative care of patients undertaking elective cardiothoracic surgical procedures.
- Worked closely with physicians, surgeons and nursing staff as part of unit team.
- Managed patient flows for unit, handling admissions and processing discharge paperwork.
- Educated patients and families about disease processes, self-care techniques, medications, discharge instructions, and follow-up care.
- Mentored junior nurses on best practices, contributing to the development of a highly skilled nursing team.
- Promoted a positive work environment through effective communication and teamwork among staff members.
Health Info Line Manager
SOUTHERN CROSS HEALTHCARE
04.1998 - 06.2006
- Responsible for day to day operations of the Health Info Line Business Unit.
- Managed recruitment, training, rostering, performance assessment and ongoing management of nursing staff.
- Monitored achievement of service targets and made staffing adjustments as needed.
- Conducted regular performance reviews and provided constructive feedback for employee growth.
- Managed a team of skilled professionals to achieve key performance indicators consistently.
- Developed and implemented reports, business correspondence and procedure manuals to streamline workflows.
- Developed and maintained business unit financial budgets.
- Developed healthcare articles and resources for the company magazine and company website.
Senior Staff Nurse
GREEN LANE HOSPITAL
06.1994 - 03.1998
- Achieved Level 3 Senior Staff Nurse position in the acute cardiology inpatient ward.
- Facilitated communication between patients, family members, and physicians regarding treatment plans.
- Educated patients and their families about treatment options and preventative measures.
- Developed and maintained productive relationships with multidisciplinary healthcare team.
- Supported development of students, new staff and colleagues.
- Managed time efficiently while providing high-quality care for multiple patients simultaneously.
Education
Diploma in Nursing (Comprehensive) - Nursing
Carrington Polytech
Auckland12.1989
First Year BSc - Successfully Completed Six Papers -
University of Auckland
Auckland12.1986
B Bursary And Higher School Certificate -
Auckland Girls Grammar School
Auckland12.1985
Skills
- Site monitoring expertise
- Clinical trial management
- Medical terminology fluency
- Regulatory compliance knowledge
- ICH-GCP guidelines knowledge
- Patient recruitment strategies
- Organizational capabilities
- Cross-functional collaboration
- Investigational Product Management
- Electronic data capture systems
- Problem-solving aptitude
- Multitasking abilities
- Organizational Skills
- Team Collaboration
- Excellent Communication
- Adaptability and Flexibility
Publications
2012, Prevention of contrast induced nephropathy during coronary angiography with a coronary sinus contrast removal system sited from the femoral vein., International Journal of Cardiology, 165, 1, e9-e10
Professional Training and Development
- August 2023 - Attended NZACREs Conference 2023, Auckland (one day)
- June 2023 - Attended CSANZ New Zealand Annual Scientific Meeting 2023, Auckland (three days)
- June 2021 - Attended CSANZ New Zealand Annual Scientific Meeting 2021, Rotorua (three days)
- October 2020 - Completed GLCC GCP (R2) Introductory Course – 6 hours V3
- September 2020 - Completed TransCelerate ICH GCP Training
- November 2019- Completed TransCelerate ICH GCP Training
- September 2019 - Attended TCT (Transcatheter Cardiovascular Therapeutics) Annual Scientific Symposium in San Francisco, USA (five days)
- June 2018 - Attended CSANZ New Zealand Annual Scientific Meeting 2018, Christchurch (three days)
- August 2017 - Completed NIDA Clinical Trials Network ICH/GCP online training “Good Clinical Practices” (six hours)
- August 2016 - Attended 10th Annual Australia and New Zealand Endoluminal Therapies (ANZET) meeting in Adelaide, Australia (three days)
- April 2016 - Attended Structural Heart Disease New Zealand Symposium in Hamilton, New Zealand (two days)
- August 2015 - Attended 9th Annual Australia and New Zealand Endoluminal Therapies (ANZET) meeting in Melbourne, Australia (three days)
- August 2014 - Attended 8th Annual Australia and New Zealand Endoluminal Therapies (ANZET) meeting in Melbourne, Australia (three days)
- August 2012 - Attended 6th Annual Australia and New Zealand Endoluminal Therapies (ANZET) meeting in Brisbane, Australia (two days)
- June 2012 - Attended Cardiac Society of Australia and New Zealand New Zealand region Annual Scientific Meeting – Auckland, New Zealand (three days)
- April 2012 - Association of Clinical Research Professionals (ACRP) New Zealand GCP Course – two day accredited course
- August 2011 - Attended New Zealand Association of Clinical Researchers (NZACRES) Annual Conference – Auckland, New Zealand (two days)
- June 2010 - Attended Cardiac Society of Australia and New Zealand New Zealand region Annual Scientific Meeting – Hastings, New Zealand (three days)
- August 2010 - Attended 4th Annual Australia and New Zealand Endoluminal Therapies (ANZET) meeting in Adelaide, Australia (two days)
- August 2010 - Attended Cardiac Society of Australia and New Zealand (CSANZ) 58th Annual Scientific Meeting in Adelaide, Australia (three days)
- August 2009 - Attended 3rd Annual of Australia and New Zealand Endoluminal Therapies (ANZET) meeting in Sydney, Australia (two days)
- August 2008 - Attended New Zealand Association of Clinical Researchers (NZACRES) Annual Conference – Auckland, New Zealand (two days)
- April 2008 - Association of Clinical Research Professionals (ACRP) New Zealand GCP Course – two day accredited course
- August 2006 – Ongoing training and development including Advanced Cardiac Life Support (ACLS), Airway Humidification, Cardiac Rehabilitation, Wound Management
- March 2006 Lion Nathan School of Business “Equipt” programme – Certificate in Workplace Efficiency.
- May 2006 - Conflict Resolution Seminar (in-house at Southern Cross)
- November 2005 - Culture and Collaboration in the Workplace (in-house at Southern Cross)
- June 2002 - Two day Leadership & Management course – included HBDI Assessments
- March 1998 - Three day leadership course – included study of Situational Leadership and Myers Briggs personality assessment
- May 1996 - Three day Leadership & Management course – Green Lane Hospital
- 1995 Cardiology Module – Green Lane Hospital Consisting of 24 hours of lectures, a workbook and teaching sessions.
Timeline
Senior Clinical Research Associate
Green Lane Coordinating Centre Ltd
08.2020 - Current
Senior Research Coordinator - Interventional - Cardiology
AUCKLAND CITY HOSPITAL
03.2008 - 08.2020
Senior Registered Nurse
MERCY HOSPITAL, EPSOM
08.2006 - 03.2008
Health Info Line Manager
SOUTHERN CROSS HEALTHCARE
04.1998 - 06.2006
Senior Staff Nurse
GREEN LANE HOSPITAL
06.1994 - 03.1998
Diploma in Nursing (Comprehensive) - Nursing
Carrington Polytech
First Year BSc - Successfully Completed Six Papers -
University of Auckland
B Bursary And Higher School Certificate -
Auckland Girls Grammar School
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