Clinical Research Associate
1 week ago
We are seeking a highly skilled Senior Clinical Research Associate to support the execution of clinical trials in Melbourne. The ideal candidate will have a strong background in site management and protocol monitoring.
Key Responsibilities:
- Perform site selection, initiation, and close-out visits to ensure compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Provide monitoring visits and site management for a variety of protocols, sites, and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans.
- Collaborate and liaise with study team members for project execution support as appropriate.
Requirements:
- Bachelor's degree in Life Sciences or other scientific/nursing disciplines is essential.
- Minimum of 4 years independent site monitoring experience for a Senior position and minimum of 18 months for all other roles.
- CRO experience is highly desired.
- Ability to travel on a regular basis, which will involve interstate travel.
- Extensive knowledge of GCP and ICH guidelines is required.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at #J-18808-Ljbffr
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