Category: <span>Company News</span>
Operational HREC Activity The COVID-19 situation has required Bellberry to rethink our Business Continuity Planning, moving from plans that recreate the whole organisation in a new location, to the ways in which we will continue to run our services while the team is wholly dispersed. We have the technology in place to allow this to happen and have been testing fully remote working techniques over the last 2 weeks. These tests cover the executive, the administration, and the function of the HREC, along with the heart of the operation: the HREC meeting itself. We are learning from each series of tests, and are confident that we will be able to continue to offer support and services in the range of possible restricted scenarios ahead. Bellberry has a schedule of 3 HREC meetings per week, and will continue to support these meetings in a way that protects the safety of our HREC members and operational team.
Business Continuity Planning for HRECs and Institutions Around the country, health systems are reprioritising their workloads in anticipation of the scenarios ahead. In light of that, a number of institutions have contacted Bellberry requesting information about utilising Bellberry HRECs as a Business Continuity backup for their own HREC. Bellberry can provide interim support to institutional HRECs and Research Offices: on a long-term, short-term or ad hoc basis. Please contact Trina O’Donnell, Operations Manager, 08 8361 3222 if you would like more information about this service.
Emergency COVID-19 related Study Reviews Bellberry has experience of emergency, fast-track reviews of pandemic-related studies. Historically, these reviews have been completed within a few days. Bellberry HRECs also have the depth of experience with routine infectious disease and vaccine studies, such as seasonal flu and diagnostics. The Bellberry HREC panel includes members with appropriate targeted expertise, including infectious disease, vaccine development, pharmacology, toxicology and immunology. We have confirmed availabilities in the next weeks and months to allow us to support COVID-19 related developments as emergency reviews. These reviews will be fast-tracked as emergency meetings in addition to the scheduled programme of meetings. We have received contacts about a number of COVID-19 studies, and will play our part in supporting fast-track development. Contact Trina O’Donnell, Operations Manager on 08 8361 3222 for more information. Bellberry will continue to monitor the emerging situation and will provide regular updates. In the meantime, for any questions, please contact the team at covidsubmissions@bellberry.com.au or 08 8361 3222.
Bellberry is delighted to announce the recent registration and certification of 4 new HRECs H, I, J and K bringing our total number of HRECs to 12. This enables us to support up to 3 HREC meetings per week.
Full details of all our Committee’s can be found on our HREC page.
Early last year Bellberry adopted the Early Phase Clinical Trial (EPCT) reviews for NSW public health sites and during that time submissions have steadily grown. To enable us to support this growth along with organic business growth, we are delighted to announce that we have recently recruited additional staff.
Joining the administration team we welcome 5 new HREC Officer’s: Phoebe Manuel, Anthea Hall, Micheala Singe, Natalie Brown and Ali Young. We also welcome Alison Branford to the new role of  HREC Co-ordinator.
Phoebe is a graduate of Pharmaceutical Science. During her university degree, she undertook work experience in a university chemistry research laboratory and at a clinical trials unit and completed a placement at an overseas pharmaceutical company. She also worked in a pathology laboratory for a year as a technical assistant.
Natalie has spent the last 12 years of her career working in administration roles within the medical field and not-for-profit organisations including Reception, Office Management, Operations and Committee Management. Natalie worked at The Australian Medical Association (AMA(SA)) prior to coming to Bellberry.
Michealea has had a varied career across multiple industries including Incident Coordinator, Document Controller and Operations Support Coordinator at a major not-for-profit organisation, Legal Secretary at a federal government agency and Network Service Manager for a national real estate franchisor.
Anthea has come from a background in medical research administration and has an Honours Degree in Health and Medical Science from the University of Adelaide.
Ali is a skilled administration and personal assistant with a background in Commercial Property. Her passion for helping people and dance teaching inspired her to change career path and focus on the medical and health industry.
Alison Branford comes to Bellberry with over 30 years of experience working in the medical industry. She has worked in varying administrative and managerial roles during this time.
The new team members are a great asset to Bellberry bringing with them a wealth of knowledge and a diversity of experience. We welcome them all to the Bellberry community!
Bellberry’s mission is to protect the welfare of research participants and to improve the quality, efficiency and effectiveness of research.
Whenever possible, we are always striving to make improvements to streamline the HREC process. To kick off in 2020, please find below an update of the significant changes that will impact research sites and sponsors. These changes will be rolling out in the coming days, weeks and months.
If you have any suggestions for future quality improvements initiatives, please email quality@bellberry.com.au.
Sponsor access to eProtocol
Sponsors and CROs wishing to access studies in eProtocol can now liaise with the site Principal Investigator to obtain access.
- Sponsors can assist with all parts of the application but cannot press ‘submit’. This remains the responsibility of the Principal Investigator.
- Principal Investigators retain control of all persons that they wish to allow access to.
Progress reports
Moving to a one-year term of approval cycle from March 2020.
- Studies approved before March 2020 will remain with current terms and conditions.
- A protocol violation report must be submitted for any progress report that is submitted after midnight on the date it is due.
- All sites urged to review their open studies to ensure their progress reporting is up to date.
Application form
The application form has had some minor question changes.
- Sites need to be mindful of these changes when applying and read all questions carefully.
- Declaration of the Principal Investigator has changed.
Document changes
There are several changes to Bellberry documentation. Many documents that you previously knew as policies are now sitting in an updated structure of Guidance and Resources. Click here for a table of all documents both old and new. This list is not exhaustive; it contains only references to the former policies.
Site monitoring
From 2020, site monitoring will occur in two ways – face to face and via desktop auditing.
- Sites will be given a template to complete for desktop audits.
Institutional responsibilities
By the end of the first quarter of 2020, there will be changes to some documents that Bellberry requests, including site-specific documents.
- We are currently working with pilot sites & sponsors to test the new process and forms.
- Sites are encouraged to spend the coming months preparing for how they will manage their internal document flow, version control and authorisation process.
- These examples relate purely to what documentation is uploaded, and each site is still responsible for creating their own ‘site application’ in the system.
As we entered 2020 Bellberry celebrated the New Year by reaching our 50th submission for NSW Health Early Phase Clinical Trials.
Bellberry HRECs were appointed by NSW Health for the review of adult Early Phase Clinical Trial (EPCT) applications early in 2019. From April 2019, all EPCT HREC trials conducted at an NSW Public Health Organisation (PHO) site had to be reviewed and approved by an appointed NSW Health EPCT HREC.
Many congratulations to our EPCT team for all their hard work in achieving this milestone!
For further information regarding applications or for submission help please visit the EPCT section of the Bellberry website or contact the Bellberry HREC EPCT Manager Jerneen Williams
Due to the recent addition of Early Phase Clinical Trial (EPCT) reviews for NSW public health sites, organic business growth and in preparation for future growth, Bellberry has recently externally advertised and recruited to a number of new roles, several of which have been successfully filled internally.
Member Coordinator
Congratulations to HREC Administrator Molly Wundenburg who has been appointed as Member Coordinator. Molly will work closely with Cathy Stevens liaising with, supporting and co-ordinating over 100 HREC members ensuring that they have all that they need to provide high-quality HREC reviews, along with our ongoing commitment to the recruitment of new members.
IT Operations and Systems Administrator
HREC Administrator Paul Smith will be joining the IT team as IT Operations and Systems Administrator to assist in supporting the businesses key functions including communication, data management, HREC submission and review and data analysis.
Both Molly and Paul have begun transitioning into their new roles and will continue to do so in the New Year.
Team Leaders
Joining Sally Sims, HREC Administrator Margaret Jelbart was successful in obtaining the position of Team Leader. Margaret commenced the role last month and brings all her previous research and governance experience, as well as a great knowledge of Bellberry processes to the role. Sheree Brozyna has also joined the Team Leader trio. Sheree comes to Bellberry having worked for a number of years as a forensic scientist. Her research, quality and analytics experience will be a great asset to the team bringing a valuable diversity of experience.
Quality Officer
We are delighted to announce that HREC Administrator Kate Fulton has recently been appointed as our new Quality Officer. After external advertising, Kate was the successful candidate amongst a strong field of applicants. Kate will be joining the Quality team early in the New Year.
Many congratulations to everyone in their new roles!
Due to the recent addition of Early Phase Clinical Trial (EPCT) reviews for NSW public health sites, organic business growth and in preparation for future growth, Bellberry has recently advertised and recruited to a number of new roles including new HREC Officers. Bellberry is delighted to announce that four new HREC Officers have recently joined the team. Maria Calarco, Dianne Palani-Stahl, Katie Trenorden and Mollie Van Rhoda all joined us in October. They come with a richness of experience including, Research, Medical Reception, HREC Administration and Recruitment. They have already become a great part of our wonderful Admin team and will be allocated their own Committee’s in due course.
Due to several internal staff changes as a result of newly created roles (further details to follow), Bellberry now has further vacancies for HREC Officers. Please visit the SEEK website for further information if you or anyone you know may be interested in this role. Closing date for applications is Fri 6 December.
For application details please visit SEEK
The last meeting of 2019 will be held on Wed 18 December with a submission deadline date of Wed 4 December. The first meeting of 2020 will be on Thursday 2 January with a submission deadline of Wed 11 December.
The Bellberry office will be closed from Tues 24 December at 5 pm until Thurs 2 January at 9 am. There will be no HREC meetings on Wed 25 December or Wed 1 January 2020 (public holidays).
Meeting Date    Submission Date
Thurs 2 Jan           Wed 11 Dec
Wed 8 Jan             Wed 18 Dec
Wed 15 Jan           Thurs 2 Jan
Meetings will continue to be held every Wednesday for 2020 with the submission date 2 weeks before the meeting date.
The International Scientific Congress is taking place next week on Wednesday 20 November. Numbers are strictly limited and there are now only a few places available! Register now to secure your place. Patient groups are reminded that fee-free places can be accessed by contacting events@bellberry.com.au
Bellberry extends sincere congratulations to our Committee B Chair, Emeritus Professor James Toouli, on being awarded the 2019 Master of the World Gastroenterology Organisation (WGO) Award in Istanbul recently. This Award is in honour of Jim’s exceptional professional and personal contributions to the field of gastroenterology and its related disciplines, and especially his efforts in the less well-developed regions of the world and in service to the populations WGO is focussed on.
The Master of the WGO (MWGO) Award is the highest honour the WGO can bestow on a member and is granted only to those individuals who have provided outstanding dedication to the mission of the WGO and achieved distinction in such areas as scholarly research, teaching, service to WGO and the community at large.
This is a capstone career award and is given in conjunction with each World Congress of Gastroenterology.
Last week our Member Manager Cathy Stevens celebrated 10 years at Bellberry! Cathy actually started her Bellberry life in 2008 as an HREC Committee member but not long after commenced her full time role as Member Manager. Cathy liaises with and co-ordinates over 130 HREC Committee members ensuring that our eight HREC Committees maintain a high calibre of membership across the board.
Cathy is a much-loved member of the Bellberry community and we the team wishes her many congratulations. Here’s to another 10 years!
Bellberry are delighted to announce that we have appointed Athena Seltsikas as HR Business Partner, to assist with our continued growth and development.
Athena has more than 20 years experience in a variety of Human Resources roles across organisations such as SA Water, ElectraNet, Weber Stephens and Telstra. In more recent times, Athena has had experience of Not For Profit organisations in the healthcare sector. In addition to supporting HR , Athena has been responsible for major HR projects such as recruitment campaigns, workforce development, leadership development and the development and deployment of training and professional development resources.
Athena will work in close partnership with other members of the Bellberry Leadership Team and the team as a whole to support change and growth.
Due to our continued growth, we seek to expand our panel of medical and scientific members on an ongoing basis. At present we are particularly interested to hear from people with clinical and/or research experience in the following areas:
- Oncology
- Pharmacology
- Neurology
- Dermatology
- General Practitioners
Knowledge and experience favourably considered for medical and scientific members (category (c) and (f) per the National Statement on Ethical Conduct in Human Research) includes:
- Knowledge and understanding of scientific and methodological requirements of research protocols
- Recent or current involvement in conducting research, particularly clinical trials relating to drugs or devices, epidemiology or behavioural/social science research
- Knowledge and understanding of the National Statement
- Knowledge and understanding of relevant national and international documents/guidelines relating to clinical research, eg TGA, GMP, EMA, FDA
- Understanding of the TGA and how it relates to clinical research
- Relevant clinical experience and formal qualification/s to practice in Australia (medical members)
- The ability to communicate well, including the capacity to listen to and appreciate the views of others, to formulate and express a considered opinion
- Sound computer skills
Meetings are held on a Wednesday evening. There is no requirement to attend a regular meeting as attendance is based on Bellberry’s need and member’s availability. Category (c) and (f) members rotate through all HRECs depending on the meeting agenda and type of expertise required. As such, the time commitment is variable, and can be tailored to suit each member. Some panel members join a Bellberry HREC meeting 3 or 4 times per year, others may join 12 or 15 times.  Interstate members join meetings remotely.
Our online software program enables members to access all relevant documents and investigator and committee correspondence via the internet.
Proposals are available to review 12 calendar days prior to a meeting. Post meeting matters are required to be dealt with promptly within a 48 hour period.
Bellberry supports education and professional development of HREC members. Initial induction training is delivered to all new HREC members and ongoing education provided with access to internal events and support for attendance at external events.
From time to time, we require community representatives, pastoral care and lawyer members (category (b), (d) and (e), per the National Statement on Ethical Conduct in Human Research) to join our team. Members in these categories are required to attend meetings rather than join remotely.
If you are interested in becoming a Bellberry HREC member please complete and submit the Committee Member Application Form.
If you would like further information, please call the Committee Manager Cathy Stevens on 08 8361 3222 or email recruitment@bellberry.com.au