A mid-sized CRO with an excellent reputation in the industry are seeking a talented Senior CRA to lead all monitoring activities in New Zealand.
You will be the first CRA in this territory and will independently monitor and work with some of the most highly innovative biotech’s with therapies at the forefront of today’s science. You’ll be well supported by a highly experienced team who are based in Australia for the meantime whilst they look to expand their team in 2021 in NZ. This is an exciting opportunity but a CRA to step up and lead activities and play a huge part in the future growth of the clinical operations team.
Permanent, full – time position
Excellent salary, benefits and perks
Remote working position in NZ
What we are looking for:
Has the ability to independently monitor sites — 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.
To be considered you should be able to demonstrate the below:
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 NZ 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
For more information and a confidential discussion please click “apply now” and an experienced recruiter will be in touch with you very quickly.