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.

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 (ARCS 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.