Clinical Trial Coordinator Ii

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With Clinical Trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized Clinical Trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

This home-based position requires candidates to reside in [Brisbane/ Sydney/ Adelaide/ Perth/ Melbourne - line manager to choose one location only. Alternatively, line manager can also specific that the CTC in Melbourne be office based or have a hybrid arrangement of home and office based]

Provides administrative and technical support. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Supports training of new staff and participates in departmental initiatives to aid in process improvements/enhancements.

• Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
• Provides system support (i.e. CTMS, Activate & eTMF) and ensures system databases are always current.
• Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• May support scheduling of client and/or internal meetings.
• Provide administrative support including but not limited to, printing documents for site files, arranging couriers to and from sites, managing returns of non-investigational project specific supplies if required.
• May review and track of local regulatory documents.
• Maintains vendor trackers.
• Supports start-up team in Regulatory submissions.
• Works directly with sites to obtain documents related to site selection.
• Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
• May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.

• Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

• Ability to work in a team or independently as required.
• Flexibility to reprioritize workload to meet changing project timelines.
• Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs.
• Good English language and grammar skills.
• Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all Clinical Trial database systems.
• Effective oral and written communication skills.
• Crucial judgment and decision-making skills.
• Capable of accurately following project work instructions.

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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 Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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