CRA II - Melbourne, Australia Remote
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges.
What You'll Do:
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills.
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
Ensures a shared responsibility with other project team members on issues/findings resolution.
Investigates and follows-up on findings as applicable.
Participates in investigator meetings as necessary.
Identifies potential investigators in collaboration with the client company.
Initiates clinical trial sites according to the relevant procedures.
Performs trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place.
Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Ensures study systems are updated per agreed study conventions.




Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.
Education
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Valid driver's license where applicable.
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
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
Proven clinical monitoring skills.
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents.
Well-developed critical thinking skills,



including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
Ability to manage Risk Based Monitoring concepts and processes.
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, attention to detail and the ability to perceive customers' underlying issues.
Good organizational and time management skills.
Effective interpersonal skills.
Attention to detail.
Ability to remain flexible and adaptable in a wide range of scenarios.
Ability to work in a team or independently as required.
Benefits
Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support.
Flexibility: Balance your work and personal life with adaptable 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.
Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs.
Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality
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.
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