Study Coordinator

7 months ago

South Brisbane, Australia Mater Group Full time

**Job no**: 499052

**Work type**: Fixed Term, Permanent

**Location**: South Brisbane

**Categories**: Registered Nurse/Midwife, Research

**About the role**

Mater Research has an exciting opportunity for a **Study Coordinator** to join our **Respiratory Clinical Trials Team. **This position will be offered as a **full time, maximum term**, 2 year contract.

As a Study Coordinator you are responsible for the day-to-day management of clinical trials. You will act as a primary coordinator for clinical trials and clinical research. Responsible for the coordination and administration of trial related activities.

This position will oversee project planning, and ensures that pre-established procedure, study protocol, data collection and regulatory requirements are followed. Overseeing recruitment and coordinate research participants as appropriate and serve as an administrative liaison for projects. This role is critical to the successful conduct of clinical trials at Mater Research.

**Salary range: $$99,374 - $111,583 (Research Lvl 8) per annum plus superannuation and salary packaging**

**What you’ll be doing**

The Study Coordinator role is vital to the successful conduct of a clinical trial. Responsible for the overall conduct of allocated clinical trials throughout the entire trial cycle (from start-up to close out):

- Management of essential documents and investigator site files
- Developing recruitment and marketing plans
- Clinical activity and data collection consistent with delegation, research protocols and level of experience
- Data entry and validation
- Compliance with monitoring plans
- Act as an administrative point of contact for trials and liaising with key stake holders
- Submission of progress reports and amendments to ensure site compliance
- Responsible for the planning and coordination of research study protocols, ongoing management of a trials and providing care and coordination of the participant during all stages of their clinical trial journey
- Responsible for the planning, coordination and participation in investigator meetings, site initiation visits, study committees and advisory board meetings
- Delegates work appropriately and ensures adequate training of levels 1 and 2 to enable them to carry out the work
- Monitors the progress of research activities and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, HREC’s, Local Governance Office and/or regulatory bodies
- Responsible for Implementation of quality control activities throughout the conduct of the trial. Facilitating and conducting general data quality checks, internal and external monitoring of the research by stakeholders such as HREC, TGA, Sponsor and Clinical Research Organisations

**About you**
- Essential _
- AHPRA nursing registration, without restrictions, and a minimum of five years experience in nursing and experience in a relevant field of research
- Demonstrated high level interpersonal skills and experience negotiating and liaising effectively with a diverse range of stakeholders (e.g. patients, families, clinic and non-clinical staff, sponsors, CROs)
- Current ICH GCP certification, with a demonstrated understanding of and commitment to the relevant guiding principles for clinical trial activities.
- Understanding of Australian Clinical trial regulatory framework and applicable guidelines such as ICH GCP as adopted by the TGA and NHRMC guidelines for clinical trials
- Strong organisational, analytical and interpersonal skills
- Excellent oral and written communication skills with competent working knowledge of Microsoft suite of programs including excel, word, teams and outlook
- Ability to operate independently exercising initiative and judgement as well as in collaboration with stakeholders
- Minimum 3 years’ full-time experience working as a clinical trial coordinator.
- Experience working within clinical research regulatory framework,
- Experience in interpreting guidelines and policy related to clinical trials.
- Experience in program coordination and stakeholder management skills.
- Proficient computer literacy.

**Why join us?**

Mater is Queensland’s largest and most innovative not-for-profit healthcare service, providing care for almost 700,000 patients a year across a network of 11 hospitals.

We are a leader in healthcare, education and research — and that’s because we employ exceptional people. **#MAKEYOURMATERMOVE**
- Via salary packaging arrangements, allocate some living expenses directly from your pre-taxable income and ultimately increase your take-home pay
- Access to package meal and entertainment expenses via salary packaging
- Access to leading education and professional development via Mater Education
- Flexible working arrangements, including work from home options where suitable
- Access to our Employee Assistance Program and on-site pastoral care teams
- Discounts to local and national business/venues for Dining/Retail

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