CRA II/ Senior CRA | Australia Wide

CRA II, Permanent Full Time

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

Performs and coordinates different aspects of the clinical monitoring and site management process. This full-time home-based position requires candidates to currently live in one or close to one of the following cities: Brisbane, Sydney, Melbourne.

Discover Impactful Work:

Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Leads procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. Develops collaborative relationships with investigational sites and client company personnel.

A Day in the Life

Keys to Success:

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Experience
• Minimal 2 years' independent clinical monitoring experience in Australia that provides the knowledge, skills, and abilities to perform the job in a clinical environment where experience is gained in clinical trials
• Valid Australian driver's license
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

• Therapeutic experience in Oncology (preferred)
• Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills and attention to detail
• Good organizational and time management skills
• Ability to remain flexible and adaptable in a wide range of scenarios
• Well-developed critical thinking skills and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Ability to work in a team or independently as required Physical Requirements / Work Environment
• 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.
• Able to perform successfully under pressure while prioritizing and balancing multiple projects or activities.
• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
• This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
• As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

Benefits

• 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 W GEA Employer of Choice for Gender Equality

Our Mission is to enable our customers to make the world healthier, cleaner and safer. 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.

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.