Cancer Clinical Trials – Mid North Coast Cancer Institute Coffs Harbour

Principal Investigators

Medical Oncology

Dr. Karen Briscoe – Medical Oncologist 

Mid North Coast Cancer Institute
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450

Phone 02 6656 5737
Fax 02 6656 5855

  • Trials Experience: 11 years Clinical Trial Experience as a Principal Investigator
  • Institution: Mid North Coast Cancer Institute, Coffs Harbour
  • Specialty Area/Board Certification: Medical Oncology, FRACP
  • Patient Recruitment Strategy: Patients are seen in the Public Hospital Clinic. Patients are referred from local GPs, other specialists and Multi-disciplinary Team meetings.
Dr. Ankit Jain – Medical Oncologist 

Mid North Coast Cancer Institute
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450

Phone 02 6656 5737
Fax 02 6656 5855

  • Trials Experience: 6 years Clinical Trial Experience as a Sub-Investigator
  • Institution: Mid North Coast Cancer Institute, Coffs Harbour
  • Specialty Area/Board Certification: Medical Oncology, FRACP
  • Patient Recruitment Strategy: Patients are seen in the Public Hospital Clinic. Patients are referred from local GPs, other specialists and Multi-disciplinary Team meetings.

Haematology

Dr. Martin Browne– Haematologist

Mid North Coast Cancer Institute
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450

Phone 02 6656 5737
Fax 02 6656 5855

  • Trials Experience: 4 years Clinical Trial Experience as a Principal Investigator
  • Institution: Mid North Coast Cancer Institute, Coffs Harbour
  • Specialty Area/Board Certification: FRACP 2006, Haematology FRCPA 2002, MRCPath (UK), Haematology 2002
  • Patient Recruitment Strategy: Patients are seen in the Public Hospital Clinic and Private Rooms. Patients are referred from local GPs, other specialists and Multi-disciplinary Team meetings.
Dr. Jolanta Benson– Haematologist

Mid North Coast Cancer Institute
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450

Phone 02 6656 5737
Fax 02 6656 5855

  • Institution: Mid North Coast Cancer Institute, Coffs Harbour
  • Specialty Area/Board Certification: MBBS, BSc, MRCP (UK), FRCPA, FRACP
  • Patient Recruitment Strategy: Patients are seen in the Public Hospital Clinic and Private Rooms. Patients are referred from local GPs, other specialists and Multi-disciplinary Team meetings.

Radiation Oncology

Associate Professor Tom Shakespeare – Radiation Oncologist

Mid North Coast Cancer Institute
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450

Phone 02 6656 5737
Fax 02 6656 5855

  • Trials Experience:ASTRO Health Services Research Committee 2004 – present (5yr appointment). Appointed to ASTRO-NCI Cancer Expert Corps Taskforce. Principal Investigator on TROG studies. Co-Investigator on qualitative, radiotherapy, chemo-radiotherapy, preventative and surgical trials
  • Institution: Mid North Coast Cancer Institute, Coffs Harbour
  • Specialty Area/Board Certification: Master of Public Health, University of NSW 2003, Fellow of the Academy of Medicine Singapore 2002 – present, Graduate Diploma of Medicine, University of NSW 2000, FRANZCR 1999 – present, MBBS University of Sydney 1992
  • Patient Recruitment Strategy: Patients are seen in the Public Hospital Clinic. Patients are referred from local GPs, other specialists and Multi-disciplinary Team meetings.

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Associated Departments
Hospital Pathology Department | Hospital Pharmacy Department | Imaging | Information Technology

Hospital Pathology Department

Pathology North Service
Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450

Helen Westaway– Manager

Phone 02 6656 7509
Helen.Westaway@ncahs.health.nsw.gov.au

Tumour Blocks
  • Patient tumour specimens may be stored at various laboratories, dependent upon where their surgery was performed
  • Tumour blocks are usually fixed in 10% Neutral Buffered Formalin, however it is advisable for this to be confirmed with the laboratory.
Reference Ranges & NATA Accreditation can be provided upon request.

Hospital Pharmacy Department

Coffs Harbour Health Campus Pharmacy,
345 Pacific Highway
Coffs Harbour NSW 2450

Janet Willis – Director

Phone 02 6656 7479
Janet. Willis@ncahs.health.nsw.gov.au

Contact: Mr Vui Shin Chong

Phone Phone (02) 6656 5770

Phone Phone (02) 6656 5795
VuiShin.Chong@ncahs.health.nsw.gov.au

Site Equipment
  • Refrigerated, Frozen and Room Temperature storage available
  • All equipment monitored and logged.
Additional Information

Please contact Vui Shin if the sponsor prefers a separate Pharmacy Contract.

Imaging

Coffs Harbour Health Campus
345 Pacific Highway
Coffs Harbour NSW 2450

Stephen Cunningham – Manager

Phone (02) 6656 7458
Stephen.Cunningham@ncahs.health.nsw.gov.au

Spiral Computerised Tomography (CT)

  • Siemens Sensation 64 spiral multi-slice scanner
  • On-site digital data stroage capacity
  • Transfer media type CD.
Bone Scan

Scanner #1

  • General Electric – Millennium with on-site digital data storage capability, transfer media type is CD

Scanner #2

  • General Electric – XRTwith on-site digital data storage capability, transfer media type is optical disc
  • Preferred compound 99mTc-methylene diphosphonate (MDP)
  • Bone scans performed at Coffs Radiology.
Other Imaging
  • Magnetic Resonance Imagine (MRI) performed at Coffs Radiology
  • X-Ray
  • PET scans are not performed locally. Patients will need to travel Newcastle, Sydney or Brisbane at the expense of the sponsor.
Additional Information

Copies of scans for Central Review can be submitted blinded digitally (CD) or film as required for all modalities.

Information Technology

Internet Connection
  • High speed internet connection available to all networked computers
  • External computers may not be connected to the network.
Source Data Verification
  • A Laptop or Desktop computer will be made available for Source Data Verification from the Electronic Medical Record System.
Research Staff
  • Roles: Research Nurses / Study Coordinators
  • Institution: North Coast Cancer Institute, Coffs Harbour
  • Office Hours: The Clinical Trial’s office is open from 8:00am to 4:30pm Monday to Friday.

Robyn Dever (CNS) (Mon – Fri)

Phone +61 2 6656 5733 

(E): NCCICoffsCTU@ncahs.health.nsw.gov.au

Annabel Pickett (CNS) (Mon – Thurs)

Phone +61 2 6656 5734 

(E): NCCICoffsCTU@ncahs.health.nsw.gov.au

Joanne Smith (RN) (Mon – Thur)

Phone +61 2 6656 5423
 (E): NCCICoffsCTU@ncahs.health.nsw.gov.au

 Charmaine Emerson (RN) (Mon, Tues and Fri)

Phone +61 2 6656 5735 

(E): NCCICoffsCTU@ncahs.health.nsw.gov.au

 

Clinical Trial Unit Specific Fax

(F):  +61 2 6656 5693 

 

Site Training, Equipment and Experience

Standard Operating Procedures

A standard set of operating procedures has been developed for all MNCLHD Oncology Trial Units. These may be obtained from the unit.

GCP

All research staff have attended formal GCP training and can provide a certificate on request. In addition, staff have attended numerous Investigator Meetings which include GCP Training.

Shipping

All research staff have completed study specific shipping training and have extensive experience shipping blood, tumour, slides, discs (imaging) and films.

Trials Experience

Clinical Trial staff have a combined total of over 30 years Medical Oncology clinical trial experience working with Collaborative Groups, Pharmaceutical Companies and Contract Research Organisations in all aspects of Phase II, III and IV studies from feasibilities and Ethics submissions to Study Close Outs.

ECGs

Staff have access to and experience with performing ECGs.

Equipment
  • Centrifuge and Refrigerated Centrifuge
  • – 80 degrees C freezer
Electronic CRFs
  • Inform
  • RAVE
  • Medidata
  • Oracle
  • ClinPhone
  • TAO.
IVRS and IWRS

All staff have experience with IVRS and IWRS.

Audits

MNCCI @ Coffs Harbour have not been audited by any regulatory bodies, however have been audited by ANZBCTG in 2006 and AGITG in 2009.

Mosaiq TM

MNCCI @ Coffs Harbour utilises an electronic Medical Record (MosaiqTM). This has been assessed to comply with the FDA code 21 CFR part 11. .

IT and Telecommunications

All study coordinators have their own desktop computer with high speed internet access.

Archiving

Off-site archiving is preferred and organised by the sponsor, however onsite archiving can be negotiated.

Site Visits

Site Initiation

This needs to be scheduled with the Clinical Trial Staff.

Monitoring

To facilitate monitors from each trial being able to access the site for monitoring purposes, the following guidelines are recommended:

  • Monitoring visits are restricted to 2 monitoring days per visit
  • The next monitoring visit should be scheduled immediately after monitoring and made directly with the study coordinator
  • The site needs to be notified if more than one monitor will be visiting
  • Satisfactory notification if a meeting with the Principal Investigator and/or pharmacy is required
  • The Study Coordinator will be available for resolving issues/queries at designated times during the day and this can be decided at the start of each visit
  • Monitoring staff will be provided with a comprehensive orientation to the clinical trials area.