Clinical Trial Coordinator | Sydney, Brisbane, Melbourne, Adelaide at THERMO FISHER BIOPHARMA SERVICES PTE LTD

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

27 Aug, 26

Salary

0.0

Posted On

29 May, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Administrative Support, Audit Readiness, Site Activation, eTMF, Regulatory Submissions, ICH GCP, MS Office, Communication Skills, Decision-making, Project Management, Digital Literacy

Industry

Biotechnology Research

Description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office, Various outside weather conditions 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. Location/Division Specific Information This home-based position requires candidates to reside in one of the following cities: Sydney, Brisbane, Melbourne or Adelaide Discover Impactful Work: Entry level role into clinical research that 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. May use local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. A day in the Life: 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., 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. 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. Keys to Success: Education Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing. Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). Knowledge, Skills, Abilities 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 and WPDs Good English language and grammar skills and proficient local language skills as needed 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 Physical Requirements / Work Environment 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.) Australian citizenship or permanent residency required Opportunity and Advancement We offer continued career advancement for our early careers Clinical Trial Coordinators to progress their careers as Clinical Research Associates. We pride ourselves on promoting from within. You can advance through the Clinical Research Associates career path when you are ready with flexible, regular promotion cycles throughout the year for Clinical Research Associates. Benefits Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer. Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues. Flexibility: Balance your work and personal life with flexible arrangements. Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave. Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you. Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development. Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality 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 125,000+ 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. Apply today! http://jobs.thermofisher.com 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

Provide administrative and technical support for clinical trials, including file reviews and system maintenance of eTMF and Activate. Coordinate site activation activities and support regulatory submissions to ensure project timelines are met.