Dr. Daniela Radulescu, MD.
Associate Investigator for Research in Coffs Harbour GP Super Clinic
Dr Radulescu is a General Practitioner and an experienced Clinical Researcher with over 10 years Involvement in clinical research. Dr Radulescu also holds a Master in Molecular Genetics.
Other doctors affiliated with BAMS would also be included as co-investigators to help in various sub-specialties medical research where their expertise is required.
Melissa moved from an administrative role with the Super Clinic to a study coordinator role with CRD in 2015. Initially she was involved in a few studies and had limited responsibilities.
Now she is fully coordinating all the aspects of the research, from Ethics submissions to data cleaning and archiving.
For more information contact:
Dr. Daniela Radulescu
Coffs Harbour GP Super Clinic- Research Department
51 Stadium Drive, Coffs Harbour
Tel: 6691 3573, Fax: 02 9049 5051
What is Clinical Research?
Clinical research is a branch of healthcare science that aims to investigate the safety and effectiveness of new medications, devices, diagnostic products and treatment regimens intended for human use.
The Australian government requires medication and devices to be tested to confirm its safety and effectiveness. It is not until this data has been assessed by the Australian government’s Therapeutic Goods Administration (TGA) that new medical products are approved for prescribing and available for purchase.
In Australia, clinical research must also conform to the Ethical Principles of the Declaration of Helsinki, as well as the international Good Clinical Practice (GCP) guidelines.
Before an interventional clinical research study can be initiated, it has to be approved by independent ethics committees that operate according the guidelines issued by the National Health and Medical Research Council (NHMRC). All of the interventional studies conducted at Coffs Harbour GP Superclinic have prior ethical approval and meet GCP guidelines.
Clinical Research Department (CRD) is attached to the Coffs Harbour GP Super Clinic (CHGPSC).
The aim of the Research Department is to conduct proper clinical research in an ethical and professional manner, either being sponsored by the government bodies, various pharmaceutical companies, clinical research organisations, or self-funded studies.
The department is working in close collaboration with all the doctors affiliated with BAMS throughout their six medical centers located in NSW North Coast, hence we have access to a diagnostic databases of more than 14,000 patients.
Melissa our Study Coordinator
In research the study coordinator role is very important, Melissa helps to keep all the things in place and lined up ready to go, registering the data in the sponsor’s systems, completing training’s, cleaning data, it’s all very involved and essential. Melissa coordinates all aspects of the research, from Ethics submissions to data cleaning and archiving.
She also has one of the clinic nurses/site staff as a nominated back-up for each specific study. Melissa is a dedicated and enthusiastic research coordinator, going the extra mile to ensure the trials are running smoothly.Due to her ongoing commitment CRD manages to achieve the research commitments and maintain high quality standards. To be part of our research trials is an honour and we often advertise for patients participation.