Study Coordinator - Clinical Trials

• Research participants & their caregivers 
• Senior Medical staff- Principal and Co Investigators 
• Multidisciplinary team members 
• PCCTU  Staff 
• Internal stakeholders as relevant to trial conduct- i.e Same Day services, inpatient wards, outpatients pathology 
• Internal human research ethics committee (HREC)  

• Clinical Trial Sponsor representatives from pharmaceutical companies and collaborative groups 
• Cancer Trials Australia 
• Research nurses and data managers at other hospitals 
• External laboratories and diagnostic imaging centres 
• Professional bodies such as VCOG & COSA & ARCS 

• Relevant tertiary qualification in Science, Health Information Management, Clinical Trial Management or a related paramedical field. 
• Understanding of medical terminology. 
• Excellent written and oral communication skills. 
• Personal confidence and initiative required to deal with people from diverse backgrounds and experiences. 
• Excellent organisational skills.      
• Attention to detail. 
• Ability to work without supervision and effectively in a group setting.  
• Ability to engender cooperation and support from colleagues. 
• Commitment to excellence in customer service. 
• Sound knowledge and understanding of the principles of GCP 

• Sound knowledge and demonstrated experience using Microsoft Office software including Word, Access, Excel and Outlook. 
• Understanding of the key concepts relating to oncology and/or haematology. 
• Previous Experience in Clinical Trial Management. 
• Post graduate qualifications in oncology, haematology and/or clinical trials research 

1. Patient screening and registration:

• Where required, ensure that all eligible patients have signed the appropriate consent forms having been duly informed of all relevant information by the Investigator and Study Coordinator.
• Ensure that Informed consent is obtained according to standard hospital practice, ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans and be actively involved in the ongoing informed consent process.
• Ensure that all consenting clinical trial participants are screened for eligibility as per the protocol.
• ensure that enrolment and randomisation are performed as per protocol
• Attends all relevant unit/departmental meetings to be informed of and to inform of upcoming / current trial activity.
• Ensures that all relevant clinical staff are informed of and invited to attend study site initiation meetings.

2.Clinical Trial Coordination

• Ensures that all trials are coordinated as per the protocol and according to ICH GCP. Verified by spot check audits where applicable.
• Ensures that all staff participating in the care of clinical trial participants have the appropriate experience and are trained in the protocol and in their trial specific responsibilities in accordance with GCP, and alerts the PI/ team leader / manager where this is not the case
• Ensures that the Principle Investigator for each trial has appropriately completed and signed the delegation of authority log for all staff participating in the trial.
• Attends start-up meetings for the clinical trials and other relevant projects
• Identifies factors influencing the successful conduct of the trial or project and takes steps to overcome identified problems
• Organises and attends meetings as required.

3. Data Collection and Entry andndash Case Record Forms

• Ensures that all registered patients can be accounted for in the trial database
• Ensures that all case report forms (paper or electronic) are completed and dispatched to the appropriate authorities within established timeframes.
• Ensures that all data recorded in CRFs can be tracked to verifiable source data
• Ensures that no source data is to be recorded directly in a CRF unless specified in the trial protocol and agreed to by all parties. This information however should be documented in the patients notes for future verification of processes
• Develops and maintains good relationships with trial sponsor representatives, trial organisers or other relevant personnel.
• Ensures that no breaches of patient, sponsor or departmental confidentiality occur and undertakes appropriate actions if errors are made
• Ensures that all data entry is completed in a timely fashion per trial and sponsor requirements.

4.Professional Development and Education

• Demonstrates a commitment to personal continuing professional development and participates in performance appraisal and review.
• Undertakes additional training in order to acquire the knowledge and skills needed to implement new study protocols from a variety of clinical specialties.
• In conjunction with Manager, identifies areas that require additional knowledge and work towards meeting the learning objectives set.
• Maintains mandatory training requirements as defined by hospital policy.

5.To function as an integral member of the Clinical Trials Team

• Develops and participates in appropriate quality activities.
• Participates in Unit and Team Meetings.
• Takes responsibility for ensuring trial participants are seen in primary study coordinators / research nurses absence and that protocol requirements are carried out according to protocol and without incident.