Catherine Bell
Cooroy
Summary
To seek and maintain a full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
29
29
years of professional experience
Work History
Senior Clinical Trial Coordinator / Registered Nurse
UniSc Clinical Trials
06.2019 - Current
- Participated in the preparation and review of regulatory submissions, ensuring accurate representation of trial data and compliance with relevant guidelines.
- Complied with research protocols by providing ongoing quality control audits.
- Conducted thorough risk assessments to identify potential issues and develop appropriate mitigation strategies early in the process.
- Followed informed consent processes and maintained records.
- Worked collaboratively with external vendors to secure necessary resources and services for efficient trial operations.
- Cultivating strong relationships with sponsors and CROs / FCEs
- Educating staff regarding protocol conduct, recruitment, protocol deviations, AE reporting and source documentation
- Developing and managing SOP and Work Instructions
- Training and mentoring new staff members.
- Maintained a high level of ethical conduct throughout all aspects of clinical trials, ensuring adherence to Good Clinical Practice guidelines and other relevant regulations.
- Streamlined trial processes with the creation of detailed study-specific procedures and guidelines.
- Developed comprehensive training materials for new team members, expediting their integration into ongoing projects without compromising quality standards.
- Managed essential document storage, ensuring compliance with regulatory requirements and easy access for audits or inspections.
- Achieved timely completion of study milestones by closely monitoring trial progress and addressing potential roadblocks.
- Ensured data accuracy by meticulously reviewing and maintaining case report forms and source documents.
- Regularly reported study progress updates to senior management, facilitating informed decision-making regarding resource allocation or strategic direction changes as needed.
Clinical Nurse / Research Coordinator
Sunshine Coast Clinical Research
01.2013 - 01.2019
- Ascertaining site feasibility
- Planning and running the study start-up
- Preparing and collecting essential documents required for regulatory and IRB/EC submission
- Reviewing and negotiating site contracts and budgets
- Developing internal systems, databases and tracking tools with trial-specific information
- Recruiting and screening subjects
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Inputting data – responding to queries in a timely manner/ensuring source is uploaded
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Gathered, processed, and shipped lab specimens.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Ensuring informed financial consent
- Providing patient education
- Supplying quotes for procedures
- Performing general nursing duties
- Developing policy and procedure (SOPs)
- Ensuring device and drug accountability
- Created educational materials for staff and patients.
Registered Nurse
Nambour Selangor Private Hospital
01.2010 - 01.2011
Practice Manager / Registered Nurse
Brisbane Rehab Pty Ltd – Dr Mark Tadros / Rehabilitation and Pain Medicine
01.2007 - 01.2008
Practice Manager / Registered Nurse
Dr Saul Geffen Pty Ltd / Rehabilitation and Sports Medicine
01.2004 - 01.2007
Registered Nurse / Relieving Practice Manager
Australian Aesthetic Surgery Centre
01.2001 - 01.2004
Registered Nurse
Mater Private Hospital, South Brisbane
01.1995 - 01.2012
Overseas Recruitment Consultant
TeachLondon
01.2002
Registered Nurse
Ballina District Hospital; County Mayo, Ireland
01.2000
CTP Injury Claims Manager
Suncorp-Metway
01.1999
Education
Bachelor of Nursing -
Queensland University of Technology
01.1994
Ipswich Girls’ Grammar School
01.1991
Skills
Therapeutic Areas:
Vaccines
Chronic Pain Conditions
Healthy Volunteers
Skin Conditions
Depression
Obesity
Migraine
Hypertension
Cardiac
- Phase 1
- Phase 2
- Phase 2b
- Phase 3
- Phase 3b
- Phase 4
Skills
- Willingness to fulfill the requirements of any challenges that are offered to me
- Ability to work very well in a team environment
- Excellent communication, organisational and interpersonal skills
- Ability to apply ICH GCP and regulatory guidelines
- Enthusiastic and highly motivated
Certificates / Training
- ICH Good Clinical Practice E6 (R2) – The Global Health Network, Current
- Safe Transport of Infectious Substances By Air – Civil Aviation Academy Australia, Current
- Advanced Life Support (Level 1) incorporating Basic Life Support - Bledisloe Medical, Current
- CPR Certificate, Current
- Emerging Leaders - Proteus Leadership, June 2023
- Project Management Fundamentals for Research and Clinical Trials (Praxis), 11/04/2021
- Provide First Aid, Current
Computer Systems / EDC
- Windows
- MSWord
- Excel
- PowerPoint
- Adobe Acrobat
- Share Point
- Viedoc
- Shared Investigator Platform
- Fusion eClinical
- 4G Clinical
- Y-Prime
- Firecrest
- IMedNet
- IMedidata
- Endpoint
- eCaselink
- Preclarus
- Exostar
- Calyx
- EMA Wellness
- Medable
- Marvin
- IBM
- Oracle
- RealTime Software
- Clinphone
- Robarts
- Clario
- Medrio
- Cenduit
- Qualio
- Docusign
- Teams
- Plexus
- Genie
- Blue Chip
- Medical Director
- MYOB
References
- Dr Robert Scott, Principal Medical Investigator, USC Clinical Trials, 0437 230 652
- James Donkin, Senior Clinical Trial Coordinator, USC Clinical Trials, 0439 898 441
- Dr Peter Georgius, Pain Medicine Specialist / Rehabilitation Physician, 0419 123 203
Timeline
Senior Clinical Trial Coordinator / Registered Nurse
UniSc Clinical Trials
06.2019 - Current
Clinical Nurse / Research Coordinator
Sunshine Coast Clinical Research
01.2013 - 01.2019
Registered Nurse
Nambour Selangor Private Hospital
01.2010 - 01.2011
Practice Manager / Registered Nurse
Brisbane Rehab Pty Ltd – Dr Mark Tadros / Rehabilitation and Pain Medicine
01.2007 - 01.2008
Practice Manager / Registered Nurse
Dr Saul Geffen Pty Ltd / Rehabilitation and Sports Medicine
01.2004 - 01.2007
Overseas Recruitment Consultant
TeachLondon
01.2002
Registered Nurse / Relieving Practice Manager
Australian Aesthetic Surgery Centre
01.2001 - 01.2004
Registered Nurse
Ballina District Hospital; County Mayo, Ireland
01.2000
CTP Injury Claims Manager
Suncorp-Metway
01.1999
Registered Nurse
Mater Private Hospital, South Brisbane
01.1995 - 01.2012
Bachelor of Nursing -
Queensland University of Technology
Ipswich Girls’ Grammar School
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