Why is this Job Description being written? New Position Replacement Position Position re-designed Position not previously described

Why is this Job Description being written? New Position Replacement Position Position re-designed Position not previously described

P O S I T I O N D E T A I L S

:

Position Title:

C

L I N I C A L

R

E S E A R C H C

O O R D I N A T O R

Division: Professional Services Department: Scientific Services

Position reports to: (role) Head, Research Governance and Platforms Location: include all possible locations 100 Roberts Road Subiaco

P O S I T I O N P U R P O S E

:

In one or two sentences briefly summarise the overall purpose of this role, i.e. broadly, what this role does and why

Provide support and advice for teams conducting clinical research across the Institute. Develop and implement policies and procedures to ensure robust research

governance and oversight of clinical research conducted under the auspices of the Institute. Develop and deliver training in conjunction with other stakeholders to ensure high quality clinical research is conducted to regulatory standards and Institutional policies and procedures

K E Y R E S P O N S I B I L I T Y A R E A S (Please list in order of importance)

Key Position Accountabilities

What are the main areas for which the position is accountable

% of Total Role

Inputs:

What are the key activities or tasks to be carried out?

Outputs:

What are the expected end results?

Measures:

How it is measured

Clinical Research Governance and Quality Assurance

30



Develop a Research Governance Framework aligned to the Code for Responsible Conduct of Research, Good Clinical Practice and all other relevant regulatory requirements.



Develop and implement a Quality Management System to include Institute wide policies and procedures that underpin the Code and ensure regulatory compliance for Clinical Research.



Design and implement initiatives for continuous quality improvement for clinical research governance.



Develop annual Audit Plans and conduct audits according to plan, support and implement corrective actions as required.

 A clear research governance framework implemented  The Institute is compliant with

the requirements of all relevant authorities

 A quality management and improvement system implemented

 Audits planned and conducted

 Quality Management System in place by agreed timescale that is fit for purpose as demonstrated by compliance with the Policy and Procedures across the Institute  Feedback from key

Support and Advice ₃₀



Provide support for contract and budget negotiation and review for all clinical research studies and trials, in conjunction with the Procurement and Contract Manager



Provide advice on ethics, governance and regulatory processes with regards to clinical research



Mentor researchers in their development, set-up and delivery of clinical research projects; including protocol development, case records forms, project management, ethics and governance applications



In conjunction with the OSH Manager, provide oversight and management of access to the Institute Clinical Suites

 A clear, consistent service support model implemented ensuring research and researchers are supported to deliver high quality clinical research

 Ongoing service delivery and improvement

 Clinical Suites access well managed

 Positive feedback from users and stakeholders

 Demonstrable safe environment and oversight of clinical suites

Education and Training

25

 Develop written education material and maximise use of appropriate technologies for accessing materials

 Prepare and deliver seminars and workshops on how to perform high quality, compliant, clinical research

 Evaluate effectiveness and track training records of new and existing staff

 Educational materials readily available to support researchers in the delivery of clinical research  Ability to report on effectiveness

and track education and training undertaken by Institute researchers

 Training plan in place

 Demonstrated utilisation of materials and acceptance to follow best practice  System in place to provide

metrics on training numbers, effectiveness and reminders for updates

General

15



Research, source and implement technology strategies to support and streamline clinical research



Champion institute policies and role model compliance



Willingly take on projects relevant to position

 New technologies implemented  Respected go to person and

member of the Institute

 Feedback from stakeholders and peers

E S S E N T I A L S K I L L S

,

K N O W L E D G E A N D E X P E R I E N C E

:

Qualifications:

what are the minimum educational, technical

or professional qualifications required to competently perform role  A university degree relevant to health and medical research or equivalent experience

Skills, Knowledge & Experience:

 Experience in the conduct and management of clinical research including clinical trials

 Thorough knowledge of the regulatory landscape and requirements that apply to human research gained by training and experience

 Highly developed interpersonal skills

 Comfortable with public speaking and demonstrated ability to run seminars and workshops for a diverse range of staff within the same session

 Excellent customer focus skills

 Ability to work independently with minimal supervision, a self-starter and prioritize own work load in response to time frames and deadlines

 Ability to use new approaches to streamline work functions

 Ability to listen and learn and engender trust among various stakeholders

D E S I R A B L E S K I L L S

,

K N O W L E D G E A N D E X P E R I E N C E

:

Qualifications: what are the minimum educational, technical

or professional qualifications required to competently perform role

Skills, Knowledge & Experience:

 Industry, academic and healthcare research experience

 Experience in and adherence to strategic planning, work planning and reporting  Change management

S C O P E

:

Financial accountability:

Does this role have accountability for a budget?



No

People responsibility:

Does this role have any direct reports or indirect reports (through direct reports)?

O R G A N I S A T I O N A L C H A R T

:

(please complete using position titles or insert diagram below)

Next level of supervision

Immediate level of supervision

Other roles reporting to immediate supervisor

Direct reports (role x no.)

A D D I T I O N A L I N F O R M A T I O N

:

is there any additional information that needs to be understood to explain this role?

This role is a 2 year fixed term contract position

Animal Welfare

Officer

Data Services

Clinical Research

Coordinator

Laboratory

Manager

Bioresources

Manager

Head, Research

Governance and

Platforms

Chief Operating

Officer