
Clinical Trials Expert
2 weeks ago
As a seasoned professional in Clinical Trials, you will be responsible for implementing a tailored approach to meet the clinical trial requirements of our esteemed sponsors. This entails working closely with their teams and understanding their objectives to promote site capabilities and performance through positive engagement with various stakeholders.
Your key responsibilities will include:
- Promoting site capabilities and performance through effective engagement with Sponsors, Clinical Research Organizations, regulatory authorities, and other stakeholders.
- Managing Sponsor queries and concerns, and matters related to staff in a diplomatic manner.
- Actively engaging with the Business Development team to drive business growth.
- Consulting with the Operations Manager to optimize recruitment opportunities for all participants.
- Building and maintaining close relationships with our recruitment partners.
- Tailoring pre-screening activities as required by the protocol and the business.
- Implementing solutions to challenges that impede recruitment efforts.
- Acting as a consultant for study feasibility reviews.
- Attending conferences both locally and internationally.
Business Efficiency:
You will also play a key role in ensuring efficient operations across various business functions. This includes:
- Collaborating closely with the Trial Advancement Team to ensure any queries are answered rapidly and efficiently.
- Working collaboratively with the Clinical Trial Team to ensure adequate resources are available to conduct trials.
- Ensuring compliance with consent requirements outlined in trial protocols.
- Participating in an on-call consultant roster for clinical trials.
- Screening Fails at par with other sites.
- Improving patient care by being a resource to other investigators.
Business Quality:
Furthermore, you will contribute to enhancing business quality through:
- Adapting to the needs of the trial, the Sponsor, and the organization.
- Proactively supporting and mentoring novice principal investigators.
- Participating in relevant Safety Committees when invited.
- Performing formal evaluations of study processes at the end of each study, with the aim of improving efficiency and effectiveness.
- Undertaking necessary training to maintain competency as a Principal Investigator, as determined by the Learning Management System, individual trials, and Good Clinical Practice requirements.
Requirements:
To be successful in this role, you must possess the following qualifications:
- Unrestricted General and/or Specialist Registration with AHPRAC.
- Australian Medical Indemnity Insurance.
- Australian Citizenship or Permanent Residency.
- Experience working in Clinical Trials.
- Experience working in a primary care setting.
- Willingness to travel locally and internationally.
Seniority Level: Executive
Employment Type: Full-time
Industry: Hospitals and Health Care, Pharmaceutical Manufacturing, Biotechnology Research
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