Research Staff

Names:

Mrs. Joanne Smith (Clinical Nurse Specialist)

Mrs. Michelle Daly

Mr. Chris Hobson

Telephone:

+61 (0) 2 6656 5733 /
+61 (0) 2 6656 5053

+61 (0) 2 6656 5735

+61 (0) 2 6656 5734

Joanne.Smith@ncahs.health.nsw.gov.au
Michelle.Daly2@ncahs.health.nsw.gov.au
Chris.Hobson@ncahs.health.nsw.gov.au

Role:

Research Nurses / Study Coordinators

Institution:

North Coast Cancer Institute, Coffs Harbour

Address:

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

Facsimile:

+61 (0) 2 6656 5855

Feasibilities:

Please contact the Research staff regarding potential studies.

Office Hours:

The Clinical Trial's office is open from 8:00am to 5:30pm Monday to Friday.

Standard Operating Procedures:

Coming soon!

GCP:

All research 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. The Trials Manager has current IATA accredition.

Trials Experience:

Clinical Trial staff have a combined total of 5 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

Electronic CRFs:

• Inform
• RAVE
• Medidata
• Oracle
• ClinPhone
• TAO

IVRS:

All staff have experience with IVRS

Audits:

NCCI @ Coffs Harbour have not been audited by any regulatory bodies, however have been audited by ANZBCTG in 2006.

Mosaiq^TM:

NCCI @ Coffs Harbour utilises an electronic Medical Record (Mosaiq^TM). This has been assessed to comply with the FDA code 21 CFR part 11. The assessment worksheet can be found here, whilst the signature page of the assessors can be accessed by this link.  This letter summarises how Mosaiq^TM complies and is signed by the Director of Area Cancer Services, A/Prof Tom Shakespeare.

IT & Telecommunications:

All study coordinators have their own desktop computer with high speed internet access and international phone and fax lines.

Site Equipment:

Centrifuge (not refrigerated)
-20^oC and -70^oC freezers

Off-site archiving is preferred and organised by the sponsor.