OverviewClinical Research Associate (CRA) II/ Senior CRA (FSP) | Melbourne, Sydney, BrisbaneThis is a home-based position and preferably based in Melbourne, Sydney or Brisbane.ResponsibilitiesMonitors investigator sites with a risk-based monitoring approach: apply root cause analysis (RCA), critical thinking and problem-solving skills to identify site process failures and corrective/preventive actions to bring the site into compliance and decrease risks.
Ensure data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
Assess investigational product through physical inventory and records review.
Document observations in reports and letters in a timely manner using approved business writing standards.
Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of identified issues and timely data recording.
Conduct supervising tasks in accordance with the approved monitoring plan.
Participate in the investigator payment process.
Ensure shared responsibility with other project team members on issue/finding resolution.
Investigate and follow-up on findings as applicable.Participates in investigator meetings as vital.
Identify potential investigators in collaboration with the client to ensure acceptability of qualified investigative sites.
Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH-GCP obligations, making recommendations where warranted.
Perform trial close out and retrieval of trial materials.Ensure that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations.
Conduct on-site file reviews as per project specifications.Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.Respond to company, client and applicable regulatory requirements, audits and inspections.Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.Contribute to other project work and initiatives for process improvement, as required.QualificationsEducation and ExperienceBachelor's degree in a life sciences field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.
Valid driver's license where applicable.Therapeutic experience in Oncology essentialPhase I experience essentialKnowledge, Skills and AbilitiesProven clinical monitoring skills.Understanding of medical/therapeutic area knowledge and medical terminology.Solid understanding of ICH GCPs, applicable regulations and procedural documents.Solid critical thinking, investigation, root cause analysis and problem solving abilities.Ability to manage Risk-Based Monitoring concepts and processes.Good oral and written communication skills; ability to communicate effectively with medical personnel.Customer-focused with strong listening, attention to detail and ability to perceive underlying issues.Good organizational and time management skills; effective interpersonal skills; attention to detail; flexibility and adaptability.Ability to work in a team or independently as required.Good digital literacy: solid knowledge of Microsoft Office and ability to learn appropriate software.Good English language and grammar skills; good presentation skills.Australian citizenship or permanent residency required.Location & ScheduleLocation: Home-based, preferably Melbourne, Sydney or Brisbane.
Schedule: Standard (Mon-Fri).
Office environment.
This role involves clinical trials conducted in 100+ countries and collaboration across PPD clinical research portfolio.Company & BenefitsThermo Fisher Scientific Australia supports a supportive culture focused on integrity, intensity, involvement, and innovation.
We offer competitive remuneration, an annual incentive plan bonus, and a range of employee benefits including:Health & Wellbeing: comprehensive benefits, wellness programs, and an Employee Assistance ProgramFlexibility: flexible work arrangementsExtra Leave: generous leave policies, including the option to purchase additional leave, paid birthday leave, and company-paid parental leaveCharitable Giving & Volunteering: paid volunteer time to support non-profit organizationsLearning & Development: access to Thermo Fisher Scientific University Plus, LinkedIn Learning, workshops, and mentorship programsThermo Fisher Scientific Australia WGEA Employer of Choice for Gender EqualityWe offer employment with an innovative organization and strong career development prospects.Seniority levelNot ApplicableEmployment typeFull-timeJob functionResearch and ScienceIndustries: Pharmaceutical Manufacturing and Biotechnology ResearchRecertification or updates may be required; referrals increase your chances of interviewing.
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📌 Clinical Research Associate (Cra) Ii/ Senior Cra (Fsp) | Melbourne, Sydney, Brisbane
🏢 Thermo Fisher Scientific
📍 Darwin