A CTA job opportunity in a global leading CRO company.
Your new company
A global sizeable CRO within the pharmaceutical healthcare industry. With a brand that is recognised worldwide and strong presence in Hong Kong and worldwide. They have excellent reputation for providing clinical service and the current opportunity will be a CTA position to a global top-tier pharma whom it has a robust pipeline of promising new medicines to help patients.
Your new role
Working fully embedded within the local clinical team at our client's offices, the Clinical Trial Assistant plays a key role in the success of global clinical trials at a local level. The tasks undertaken by a CTA are varied and can include:
* Prepare, collect, review, submit and track EC & HA documents required for site initiation.
* Ensure that all assigned start up activities are on track and support study deliverables.
* Participate in team meetings to report startup progress and escalate site issues that might impact the startup timelines.
* Review and customize country and site-specific informed consent form for compliance with local requirements.
* Review and update study documents when there are changes in study personnel/study amendments. Prepare and submit amended documents, e.g. protocol, IB, ICF to EC & HA within required timelines.
* Liaise with study team and CTA hub regarding document submission requirements if applicable.
* Liaise with EC & HA regarding submission/approval issues.
* Ensure high quality site documents are filed in eTMF in a timely manner according to required timelines.
* Prepare and negotiate site contracts and budgets with sites.
* Assist clinical research team in distributing safety reports to investigators, prepare and track safety report submission documents for investigators/EC/HA.
* Perform other duties as assigned by management.
What you'll need to succeed
We want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
* Degree in healthcare or scientific discipline
* Minimum two years pharmaceutical / CRO / clinical site experience especially with submission, budget and contract or other relevant experience. Four years or more experience will be considered for higher position.
* Ability to prioritize, coordinate, and organize different tasks. Deliver on commitments.
* Proactive to follow up task with internal/external stakeholders, be attentive to details on documentation.
* Ability to work with minimal supervision in a fast-paced environment with sense of urgency.
* Solid understanding of clinical development process including GCP and ICH fundamentals.
* Good computer literacy
* Excellent communication and interpersonal skills, with an ability to negotiate
What you'll get in return
As a Clinical Trial Assistant, you will have the opportunity to experience the full lifecycle of a project and genuinely contribute to drug development and improving patients' lives.
What you need to do now
If you're interested in this role, kindly email your CV to [email protected]