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Overview
This home-based position requires candidates to reside in Auckland, New Zealand.
The role involves providing administrative and technical support for clinical trials, aiding site activation, and supporting collaboration with investigators and site personnel to conduct feasibility assessments and trial operations.
Responsibilities
Provides administrative and technical support; supports audit readiness by ensuring files are reviewed according to the organization\'s SOP and department guidance.
Aids the development of the critical path for site activation within assigned projects to support rapid site activations.
Represents the organization in the global medical research community; may develop collaborative relationships with investigators and site personnel.
Develops local knowledge of sites in the respective market and contributes to site lists for feasibility activities and site tiering.
Acts as a buddy during onboarding and supports training of new staff; participates in process improvements.
Performs department, Internal, Country and Investigator file reviews and documents findings in appropriate systems.
Ensures allocated tasks are performed on time, within budget, and to high quality; proactively communicates risks to project leads.
Provides system support (Activate & eTMF) and maintains current system databases.
Performs administrative tasks on assigned trials, including processing documents for the Client (eTMF), distributing communications, and providing documents / reports to internal team members.
Supports scheduling of client and / or internal meetings; maintains vendor trackers; may work with sites to obtain documents for site selection.
Collaborates with teammates to achieve project goals and discusses site issues and risks with appropriate clinical personnel.
May conduct phone interviews with physicians and site personnel to discuss standard of care and obtain protocol-level input for trial optimization.
Qualifications
Bachelor\'s degree in Life sciences preferred.
2+ years (or equivalent) of relevant experience.
Ability to work in a team or independently; flexibility to reprioritize workload to meet changing timelines.
Solid understanding of applicable country regulations, ICH Good Clinical Practices, and SOPs / WPDs.
Good English language and grammar skills; proficient in local language as needed.
Proficient in MS Office (Word, Excel, PowerPoint) and able to learn clinical trial database systems.
Effective oral and written communication; sound judgment and decision-making skills; ability to follow project work instructions.
Physical Requirements / Work Environment
Ability to communicate with diverse groups; work upright and stationary as required.
Proficiency with standard office equipment and technology.
Ability to work under pressure while prioritizing multiple projects; travel may be required.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
Our mission is to enable customers to make the world healthier, cleaner and safer.
We are 100,000+ colleagues strong, with values including Integrity, Intensity, Innovation and Involvement.
Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Job Details
Employment type : Full-time
Job function : Research and Science
Industries : Pharmaceutical Manufacturing and Biotechnology Research
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Clinical Coordinator • Auckland, Auckland, New Zealand