Haematology Clinical Research (Research Assistant)

Research Assistant – General, Haematology Research 

About the Role

Monash Health Haematology has a large Clinical Trials Unit and utilises the purpose-built state of the art Clinical Trials Unit at the Monash Health Translation Precinct to implement new and exciting clinical trial opportunities for our patients. Our Clinical Trials Unit currently runs ~120 clinical trials in all aspects of haematology, focussing on malignant as well as haemostasis/thrombosis trials, and offers patient-centred care to patients with complex needs. This is a dynamic and fast-paced team, working in an ever-evolving developmental areas such as targeted therapy, immunotherapy, and chemotherapy. A strong collaboration between the unit, the trial sponsors, and Monash Health is required in planning, coordinating and implementing trials to ensure the best possible care for trial patients. 

The purpose of this position is to effectively and efficiently manage the data relating to various national haematological registries and the multiple studies active within the unit. This includes data entry for national patient registries, trials, maintaining patient databases and archiving studies as they are closed. The Research Assistant will work in conjunction with other members of the Haematology Research Unit. A strong collaboration 

between the unit, the trial sponsors, and Monash Health is required in planning, coordinating and implementing trials to ensure the best possible care for trial patients. 

Key result areas:

• Organization in performing assigned work including, but not limited to, timeliness, neatness and success in managing multiple tasks 

• Develop an expertise in data entry using the databases chosen by the sponsors, national registries as well as the Clinical Haematology Databases, thus decreasing data queries by providing accurate and timely data entry for our stakeholders 

• Effective communication of all protocol related issues to the appropriate staff including but not limited to the sponsors, the Principal Investigator, the Coordinators, the Clinical Trial Manager and the HREC 

• Assist with the management of studies at archiving stages if needed 

• Maintenance of complete and accurate Investigator Site Files and related regulatory documentation 

• Professional conduct at all times

Operational / Clinical Responsibilites

Responsibilities and accountabilities to include but not limited to the following: 

Data Entry:

• Manage data entry for active studies 
• Manage and Maintain data entry and databases for several national haematological registries 
• Maintain patient databases for Clinical Haematology 
• Clear the backlog of data entry for registry databases 

Audits:

• Assist the Clinical Trial Coordinators to Maintain Site Files 
• Assist with providing all required documents to the auditors 
• Assist with making all appropriate corrections as required by auditors

Archiving:

• Ensure all documentation is packed, filed and labelled appropriately 
• Store all files in a permanent and safe location for the required amount of time as agreed to in the Clinical Trial Research Agreement 

Operational:

• Sending trial samples to collaborative groups via post office for processing. 
• Attend team and unit meetings as appropriate 
• Maintain constant communications with the Clinical Trial Coordinators and the Manager 
• Assess strategies to regularly improve efficiency 
• Actively participate in the quality improvement of the unit 

Clerical duties:

• Answer and screen telephone calls 
• Relay messages to the Research Unit team and ensure they are followed through 
• Address and welcome visitors and patients appropriately to promote a positive image of the Haematology Research Unit and Monash Health more generally 
• Support the Clinical Trials Manager and Co-ordinators with clerical support as required 

Key performance indicators:

• Timeliness of data entry and task completion 
• Accuracy of data entry 
• Positive communication with research team, in particular Research Manager (Finance & Contracts), Research Coordinators and Research Assistants 
• Maintenance of professional conduct 

About You

Qualifications/registrations/licences (italics indicate desirable):

• Interest and/or experience in clinical research 

• Experience with medical terminology, medical data entry, medical database systems 

• Medical Student or  Nursing or Haematology training / discipline 

Technical skills/knowledge/experience:

• Excellent interpersonal and communication skills, both verbal and written 

• Experience with medical database entry / knowledge of medical terminologies / retrieval of data from patient’s hospital records and laboratory reports 

• Ability to work as part of a team yet able to work independently 

• Demonstrates the ability  to keep complete and organized records 

• Ability to grasp the concepts of each protocol 

• Well-developed conflict management skills