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Clinical Trials Coordinator

Clinical Trials Coordinator

We are currently seeking a Clinical Trials Coordinator

Purpose of the Position:

The primary role of the Clinical Trials Coordinator (CTC) is to manage multiple clinical trials with the direction of a Principal Investigator and the Clinical Trials Centre Manager.  The CTC independently supports, facilitates and coordinates the clinical and administrative activities required to ensure patient safety and comply with regulatory requirements, ethical guidelines, standard operating procedures and clinical trial protocols.  While the role is primarily based at Wesley Medical Research, the CTC is required to attend other hospital facilities (e.g. St Andrew’s War Memorial Hospital, The Wesley Hospital) to effectively coordinate clinical trials.

Responsibilities of the Role

  • Screen and enrol appropriate participants for clinical trials as per clinical trial protocols.
  • Ensure that clinical trial participants are consented according to the principles of Good Clinical Practice (GCP) and the conditions of Human Research Ethics Committee approvals.
  • Liaise with Investigator to schedule and conduct participant clinic visits, ensuring that all assessments are completed and all required data is collected.  Participant enrolment and follow-up may necessitate some after-hours involvement of the Clinical Trials Coordinator.
  • Perform protocol-specific health assessments, procedures and therapeutic administration consistent with clinical qualifications.
  • Ensure all biological samples are collected, stored, processed and shipped as per the clinical trial protocol and applicable storage and handling regulations.
  • Maintain all required study documentation, including screening/enrolment logs, participant identification logs etc.
  • Maintain all required study supplies and ensure facilities are kept in an orderly manner.
  • Maintain trial-specific databases, ensuring that all data is entered in accordance with defined timelines and that database lock metrics are met.
  • Maintain the Clinical Trials Management System.
  • Assist the Finance department with all required Accounts Payable/Accounts Receivable activities (e.g. participant reimbursement, Sponsor invoicing etc).
  • Ensure Investigational Product is received, stored, maintained, dispensed and administered in accordance with regulatory requirements and clinical trial protocols.
  • Report serious adverse events and adverse events according to GCP and the clinical trial protocol to ensure patient safety.
  • Submit all required documentation to the Human Research Ethics Committee on an ongoing basis.
  • Collaborate with internal and external stakeholders to develop a constructive, team-orientated environment that provides a positive experience to Sponsors, trial participants, external contractors and other internal staff.
  • Ensure all research activity is conducted in accordance with Standard Operating Procedures (SOPs) and research-specific protocols.
  • Assist with the completion of Site Feasibility Questionnaires.
  • Liaise with Sponsors, Principal Investigator and internal stakeholders to coordinate Site Selection and Site Initiation Visits.
  • Attend Investigator Meetings and all other relevant training sessions as required.
  • Responsible for the development and utilisation of study-specific source documentation to ensure that data is recorded accurately and in accordance with Good Documentation Practice.
  • In consultation with the Clinical Trials Centre Manager and Principal Investigator, develop and implement recruitment strategies to meet study-specific recruitment targets.
  • Ensure all research activities managed by Wesley Medical Research are carried out in accordance with Good Clinical and Laboratory Practice (GCP & GLP) and in line with National Health and Medical Research (NHMRC) standards and Australian laws and regulations.
  • Perform any other duties as required to ensure effective delivery and management of research at Wesley Medical Research.

About You:

The successful candidate will ideally present with the following:

Essential

Knowledge and Skills

  • Current AHPRA registration as a Registered Nurse with demonstrated clinical trials experience
  • Demonstrated ability to work both independently and in a multi-disciplinary team in an effective, proactive and cooperative manner
  • High level of initiative and flexibility and ability to meet deadlines while balancing multiple priorities
  • Knowledge of relevant legislation and policies including, Guidelines for Good Clinical Practice, National Health and Medical Research Council and Therapeutic Goods Regulation plus an understanding of Human Research Ethics Committees procedures
  • A flexible, proactive attitude, including the capacity to acquire new skills and multitask
  • Excellent organisational skills and the ability to prioritise tasks effectively
  • Excellent interpersonal skills, including the ability to interact effectively with patients and multi-disciplinary medical and scientific staff
  • Proficiency in a wide range of computer applications, including use of databases, spreadsheets and MS Office
  • Commitment to Wesley Medical Research to promote quality in research and enhance the reputation of the organisation and its researchers
  • Demonstrated commitment to and understanding of workplace health and safety principles
  • Driver’s licence

Highly Desirable

  • Experience and currently recognised competencies (or commitment to upskilling) in related clinical skills such as venipuncture, cannulation and the performance of electrocardiographs
  • Knowledge of The Wesley Hospital’s and UnitingCare Health policies and regulations which impact the position

Personal Attributes

  • A self-starter with significant initiative and judgement is required while working within a complex organisational environment.

How to Apply:

If this sounds like you, please apply below, submitting your CV and Cover Letter addressing your experience against the above criteria and any significant achievements you think we should know about to careers@wesleyresearch.org.au.

In return, we offer a competitive salary with significant N-F-P salary sacrifice benefits, a dynamic and rewarding work environment and an opportunity to be part of an organisation that genuinely makes a real difference in the lives of the people it deals with.

Job Category: Research
Job Type: Full Time
Job Location: Auchenflower

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Wesley Medical Research

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