Clinical Research Associate I – II
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Job Description
Clinical Research Associate managing clinical trial sites in Australia. Ensuring compliance with protocols and building relationships with site staff.
Responsibilities:
- Act as Parexel’s direct contact with assigned sites
- Assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
- Perform problem-solving to address and resolve site issues
- Build relationships with investigators and site staff
- Facilitate and support site with access to relevant study systems
- Ensure sites are compliant with project specific training requirements
- Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary
- Address and resolve issues at sites, including additional training and communication
- Collect, review, and approve updated/amended site documentation
- Perform on-site visits including Qualification and Initiation visits
- Conduct remote visits/contacts as requested/needed
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations
- Ensure timely and accurate completion of project goals and update applicable trial management systems
- Provide strategy for efficient project planning and goal completion
- Ensure that assigned sites are audit and inspection ready
Requirements:
- CRA experience from AUS or NZ is required (at least 1 year of independent monitoring)
- Sound problem solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Advance presentation skills.
- Client focused approach to work.
- Ability to interact professionally within a client organization.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of the issues that arise.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Strong interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
- Effective time management in order to meet study needs, team objectives, and department goals.
- Developing ability to work across cultures.
- Shows commitment to and performs consistently high-quality work.
- Able to accommodate extensive travel time requirements, according to task allocation/phase of the study assigned.
- Holds a driver’s license where required.
Benefits:
- Open to consider experienced CRAs based in Melbourne or Sydney.
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