Senior CRA / CRA II
1 day left
- Experience Level
- Experienced (non-manager)
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic Clinical Research Associate II / Senior CRA to join our team in New Zealand! This role will be fully home-based, supported by an Australian manager. This is a permanent opportunity.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
Imagine. Inspire. Innovate. Impact. With Us.
This is an exciting opportunity to join a dynamic and innovative CRO. You will be responsible for performing clinical trial monitoring activities and have some involvement in start-up activities in compliance with trial protocol, ICH-GCP, applicable local laws and regulations, company policies and quality standards.
You will manage study-site activities to ensure collection of accurate clinical data within prescribed timelines; identify, resolve, mitigate, and escalate risks and issues; take responsibility for multiple studies; and work independently with team support. This role will be fully home-based, supported by an Australian manager.
The successful candidate will be located in New Zealand.
You’ll be accountable for:
- Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
- Scheduling site visits for monitoring as required by protocol monitoring visit windows.
- Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
You’ll be responsible for:
- Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
- Planning day-to-day activities for study monitoring and setting priorities by site.
- Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
- Working with the line manager and CM to ensure that visit metrics are maintained as required.
- Gauging the quality of clinical deliverables and addressing quality issues with team members.
- Providing accurate and timely trip reports and records of hours worked.
- Managing query resolution with study sites and Premier Research data management operations.
- Maintaining the project tracking system of subjects and site information.
- Participating in Investigators’ Meetings as assigned by Project Managers.
- Maintaining contact with investigator sites via telephone calls between visits.
- Ensuring adherence to study timelines and budgets.
- Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
You’ll also contribute by:
- Being a resource for other CRAs, mentoring junior-level staff and sharing knowledge and best practices.
- Participating in training offered to increase therapeutic knowledge and keeping current with regulations and TGA guidance.
- In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
- Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.
You’ll need this to be considered:
- Education: Undergraduate degree or its international equivalent in clinical, science or health related field from an accredited institution or a licensed healthcare professional
- Fluent verbal and written English
- Previous clinical research and independent site monitoring experience
- Working knowledge of New Zealand and international regulatory procedures, and monitoring activities
- Excellent team player, collaborative and able to build an effective team.
- Ability to multitask and work effectively in a fast-paced environment
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Accountable, dependable and strong commitment
If you are looking for a career within a transparent and non-hierarchical organisation then please contact us at the email address listed below. We are open minded and flexible regarding the talent we recruit, ultimately we are looking for people who will share in our vision and realize the importance of communication, building relationships and adhering to the highest quality standards.
You must be eligible to live and work in New Zealand in order to apply for this role.
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