Erin Mander
Sydney,NSW
Summary
Multi-talented clinical research professional proficient in handling patient information, laboratory samples, and compliance procedures for different clinical trials. Well-organized and hardworking with excellent communication and planning skills.
Skilled clinical research coordinator with background in managing and overseeing clinical trials. Experience includes coordinating with research teams, ensuring compliance with protocols, and managing participant recruitment and data collection processes. Possess strong organizational skills, ability to manage multiple tasks efficiently, and capability to ensure accuracy in documentation and reporting. Contributed to improving trial procedures and enhancing data integrity in previous roles.
Overview
36
36
years of professional experience
Work History
Managing Director
Nurse Next Door Northern Beaches
Narrabeen
04.2023 - 07.2024
- Cultivated relationships with customers, vendors, partners and other external stakeholders.
- Implemented process improvements initiatives across various departments within the organization.
- Ensured compliance with applicable laws, regulations, policies, and procedures related to business operations.
- Oversaw day-to-day operations of the company while coordinating with staff members.
- Used expertise to cultivate relationships with existing clients, develop new client relationships and win business.
- Delegated work to staff, setting priorities and goals.
- Prepared staff work schedules and assigned team members to specific duties.
Clinical Research Coordinator
Medical Oncology RNSH
Narrabeen
04.2021 - 04.2023
- Performed patient assessments, collected and analyzed data, and prepared reports.
- Reviewed medical records for accuracy of source documentation prior to database lock.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Took vital signs and collected medical histories as part of study protocols.
Clinical Research Coordinator
Endocrinology RNSH
03.2020 - 03.2021
- In clinic management of patients on Diabetes, pregnancy and Menopause studies
Clinical Research Nurse
Illingworth Research Group
09.2019 - 03.2021
- In home/school/office clinical trials in multiple therapeutic drug and device areas
- Duties include patient observations, venipuncture, laboratory process of samples, performing CTGs, and completion of CRF
- Casual role
SCRA
Syneos Health
01.2019 - 09.2019
- Phase III Respiratory Trial
Perinatal Clinical Trials Coordinator
NHMRC Clinical Trials Centre
01.2018 - 10.2018
- Coordinator of trials in pregnant women worldwide at risk of becoming anaemic or developing pre-eclampsia, Phase II
SCRA/ Project Manager/Regulatory Affairs /Manager
PCRG
05.2016 - 12.2016
- Responsible for managing various device trials throughout Asia Pacific
- Therapeutic areas include cardiovascular health (Heart Failure), and Parkinson's Disease
- Regulatory responsibilities include liaising with the TGA for CTN and study closure, and maintaining company portfolio
SCRA
Inventiv Health
09.2015 - 05.2016
- Responsible for all aspects of monitoring clinical trials, in Phase 1b to Phase III trials in Melanoma, Cardiovascular Disease (LDL receptor), Multiple Myeloma and Acute Lymphoblastic Leukaemia
Clinical Trials Manager
Northern Cancer Institute Sydney
01.2014 - 09.2015
- Create, develop and manage a new Clinical Trials Unit, train and manage study coordinators and manage own portfolio of studies from Phase I to III
- All initial ethics submissions and approvals with private and public HREC bodies, with ongoing responsibility for portfolio of submissions safety and annual reports
- Communication and correspondence with RGO
- Establish Laboratory for biological specimen processing and storage
- Co-ordinate potential sponsor feasibility, and site selection process, and study start up activities
- Negotiate all new contracts for new clinical trials and ongoing management of budgets, invoicing and finance for all studies
- Organisation and negotiation of all outsourced radiology, pathology and pharmacy compounding contracts
- Develop and maintain all trial tracking systems, electronic and paper
- Attend investigator meetings and site initiation visits
- Prepare monthly reports for the Board of Directors, Clinicians and RGO
- Staff rostering
- Co-ordinate and run monthly unit meetings, present at nurse in services
Midwife/nurse co-ordinating client care
IVF Australia
03.2012 - 07.2014
- Undergoing artificial reproductive therapies (venepuncture; drug admin and coordination intra-uterine insemination; ultra-sonography)
SCRA
Sirtex
07.2011 - 12.2011
- Phase III medical device liver cancer trial in Australia and NZ
SCRA
Johnson & Johnson Australia
01.2008 - 02.2008
- Short term contract to assist with close out of multiple sites in the US, phase II - III HIV Cell Therapy trial
Strategic Research Services Associate
Quintiles Innovex Ltd
10.2004 - 04.2006
- Monitoring, CRA training and coordinating phase IV clinical trial in the area of sexual health, specifically genital herpes, over multiple sites (Novartis product)
SCRA
Amgen Australia
04.2003 - 10.2004
- Phase IV Nephrology pre-dialysis trial – study start up, monitoring, audit preparation, and site close out
- Responsible for 110 patients in 9 hospital sites Australia wide, and the liaison with investigators, study nurse and ethics departments at all sites
SCRA
GlaxoSmithKline
01.2000 - 12.2001
- Responsible for study initiation and monitoring of Phase 1 studies at the James Lance Medicines Research Unit at POW Hospital, Sydney, a 12 bed experimental medicine unit
- Drug trials were in the areas of AIDS, pain tolerance, CV disease and migraine
CRA/SCRA
Novogen Pty Ltd
01.1995 - 12.1999
- Responsible for initiating and developing investigator communication; Protocol and CRF development; CRN and Investigator liaison; CRA training and management, data management, reporting all results directly to Research Director
- Completed trials:
- Wound Healing Trial (Phase I)
- Menopause management (Phase II)
- Vascular Compliance Trial (Phase I)
- Cardiovascular Trial (Phase I) & Multi-centre (Phase II)
- Manage Pre-phase I trials in prostate cancer via the SAS
Research Assistant / PhD Student
Heart Research Institute, University of Sydney
01.1989 - 12.1995
- Cell Biology Research Group
First Aid Trainer
Sydney School of Business & Technology
12.2016
Birth and parenting educator
RNSH
12.2016
Ante-natal educator
Mater and RNSH Hospital
09.2012
- In labour, birth and parenting
Registered Midwife
NSW Health
01.2009
- In all matenity departments at RNS/Manly/Mona Vale Hospitals
Intellectual Property Manager
Novogen Pty Ltd
- Management of Novogen patent portfolio, nationally and internationally
- This involved extensive literature research, preparation of preliminary patent applications, and inventor liaison in the areas of cardiovascular disease, menopausal health, prostate health, osteoporosis, wound healing, cancer treatment and hormone related disorders
Regulatory Affairs Manager
Novogen Pty Ltd
- Responsible for listing two OTC products with ongoing management of international distribution and product development
- Provided scientific and technical support nationally and internationally for worldwide product distribution, dealing with both the TGA and FDA
Cardiovascular Senior Scientist
Novogen Pty Ltd
- Responsible for managing a drug development program, with research sites throughout Australia
- This involved initiating, developing and coordinating novel research in the areas of cardiovascular disease, breast cancer and prostate cancer
Education
Cert IV Education and Training -
01.2012
Bachelor of Midwifery -
UTS/RNSH
01.2008
PhD - Medicine
Heart Research Institute, University of Sydney
01.1995
BSc - Chemistry and Biochemistry
University of Sydney
01.1989
Skills
- Phlebotomy
- Research experience
- Good clinical practice
- Trial oversight
- Specimen handling
- Medication Dispensing
- Documentation requirements
- Records Maintenance
- Detailed documentation
- Project monitoring
- Monitoring visits
- Coordinating supplies
- Project Management
- Protocol development
- Study design
- Site Management
- Report Writing
- Clinical Documentation
- Patient recruitment strategies
Otherexperience
- Maternity Educator, Mater Hospital (Classes in labour, birth and parenting)
- Cell Care, casual cord blood collector
- Volunteer with disabled sailors since 2005, taking disabled and disadvantaged children and adults sailing in Sydney and NSW
- Post-natal support specialist, for parents with newborn or unwell infants
- Respite carer for Guide Dogs
- Volunteer WIRES native animal rescuer and carer
Coursescompleted
- Child Birth and Parenting Educator RPAH
- RYA Keelboat Skipper
- RYA Day Skipper
- Senior First Aid (current to Feb 2020)
- Marine Radio Operators Licence
- Safety at Sea Survival Course (current to Jan 2020)
- Medical Writing & Science Communication Course, University of Sydney
- Quintiles Introduction to CRA/Monitoring course
- Amgen CRA Training
Affiliations
- Sailing
- Yoga
- Native Animal Rescuer
Timeline
Managing Director
Nurse Next Door Northern Beaches
04.2023 - 07.2024
Clinical Research Coordinator
Medical Oncology RNSH
04.2021 - 04.2023
Clinical Research Coordinator
Endocrinology RNSH
03.2020 - 03.2021
Clinical Research Nurse
Illingworth Research Group
09.2019 - 03.2021
SCRA
Syneos Health
01.2019 - 09.2019
Perinatal Clinical Trials Coordinator
NHMRC Clinical Trials Centre
01.2018 - 10.2018
First Aid Trainer
Sydney School of Business & Technology
12.2016
Birth and parenting educator
RNSH
12.2016
SCRA/ Project Manager/Regulatory Affairs /Manager
PCRG
05.2016 - 12.2016
SCRA
Inventiv Health
09.2015 - 05.2016
Clinical Trials Manager
Northern Cancer Institute Sydney
01.2014 - 09.2015
Ante-natal educator
Mater and RNSH Hospital
09.2012
Midwife/nurse co-ordinating client care
IVF Australia
03.2012 - 07.2014
SCRA
Sirtex
07.2011 - 12.2011
Registered Midwife
NSW Health
01.2009
SCRA
Johnson & Johnson Australia
01.2008 - 02.2008
Strategic Research Services Associate
Quintiles Innovex Ltd
10.2004 - 04.2006
SCRA
Amgen Australia
04.2003 - 10.2004
SCRA
GlaxoSmithKline
01.2000 - 12.2001
CRA/SCRA
Novogen Pty Ltd
01.1995 - 12.1999
Research Assistant / PhD Student
Heart Research Institute, University of Sydney
01.1989 - 12.1995
Intellectual Property Manager
Novogen Pty Ltd
Regulatory Affairs Manager
Novogen Pty Ltd
Cardiovascular Senior Scientist
Novogen Pty Ltd
Cert IV Education and Training -
Bachelor of Midwifery -
UTS/RNSH
PhD - Medicine
Heart Research Institute, University of Sydney
BSc - Chemistry and Biochemistry
University of Sydney
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