Overview
Clinical Research Associate (CRA) II/ Senior CRA (FSP) | Melbourne, Sydney, Brisbane. Join to apply for the Clinical Research Associate (CRA) II/ Senior CRA (FSP) role at Thermo Fisher Scientific.
This is a home-based position and preferably based in Melbourne, Sydney or Brisbane.
Key Responsibilities
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis, critical thinking and problem-solving to identify site processes failures and implement corrective/preventive actions to achieve compliance and reduce risk. Ensure data accuracy through SDR, SDV and CRF review; assess investigational product through physical inventory and records review. Document observations in reports and letters using approved business writing standards. Escalate deficiencies and issues to clinical management and follow through to resolution. Maintain regular contact between monitoring visits to verify protocol adherence, issue resolution, and timely data recording. Conduct supervising tasks per the monitoring plan. Participate in investigator payments. Collaborate with other project team members on issue resolution.
- Participates in investigator meetings and identifies potential investigators to ensure qualify sites in collaboration with the client company. Initiates clinical trial sites per procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations; may make recommendations as warranted. Perform trial close out and retrieval of trial materials.
- Ensures required crucial documents are complete and in place per ICH-GCP and applicable regulations. Conducts on-site file reviews per project specifications.
- Provides trial status tracking and progress updates to the Clinical Team Manager (CTM). Ensures study systems are updated per study conventions (e.g., Clinical Trial Management System).
- Facilitates effective communication between investigative sites, the client company and the PPD project team via written, oral and electronic contacts.
- Responds to company, client and applicable regulatory requirements, audits and inspections.
- Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas with team members.
- Contributes to other project work and initiatives for process improvement as required.
Education and Experience
- Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent, with relevant formal academic/vocational qualification.
- Previous experience equivalent to 1 year as a clinical research monitor or completion of the PPD Drug Development Fellowship. Valid driver’s license where applicable.
- Therapeutic experience in Oncology is essential.
- Phase I experience is essential.
Knowledge, Skills and Abilities
- Proven clinical monitoring skills.
- Understanding of medical/therapeutic area knowledge and medical terminology.
- Solid understanding of ICH-GCPs, applicable regulations and procedural documents.
- Strong critical thinking, 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 with medical personnel.
- Customer-focused with strong listening, attention to detail and ability to address underlying issues.
- Strong organizational and time management skills.
- Effective interpersonal skills and ability to work in a team or independently.
- 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.
Benefits
- Health & Wellbeing: comprehensive benefits, wellness programs, and an Employee Assistance Program offering confidential support.
- Flexibility: flexible work arrangements.
- Extra Leave: generous leave policies, including the option to purchase additional leave, paid birthday leave, and company-paid parental leave.
- Charitable Giving & Volunteering: paid volunteer time to support non-profit organizations.
- Learning & Development: access to Thermo Fisher Scientific University Plus and LinkedIn Learning, workshops, and mentorship programs.
Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality. We offer competitive remuneration and a range of employee benefits. Thermo Fisher Scientific offers employment with an cutting-edge organization and opportunities for career development.
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📌 Clinical Research Associate (CRA) II/ Senior CRA (FSP) | Melbourne, Sydney, Brisbane
🏢 Thermo Fisher Scientific
📍 Newcastle