Senior Clinical Research Associate - New Zealand

Clinical Monitoring Wellington, New Zealand


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Clinical Research Associate II / Senior CRA to join our team in New Zealand to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.  
At Premier Research, we are science-minded and heart-centered. Join us.

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 welcoming environment with colleagues who are genuinely supportive regardless of location or seniority.
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. You will support Premier's growth in New Zealand by actively participating in site outreach and country level therapeutic activities, providing details in support of our proposal development process.
When available there may be opportunities to share your ideas and experience through participation in global initiatives.

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 organization, 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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