CRA II - Brisbane, Sydney, Adelaide, Perth
Thermo Fisher Scientific
Overview
Join to apply for the CRA II - Brisbane, Sydney, Adelaide, Perth role at Thermo Fisher Scientific.
Work Schedule: Standard (Mon-Fri). Environmental Conditions: Office.
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 Information
This is a home-based position and preferably based in Brisbane, Sydney, Adelaide, Perth.
Key Responsibilities
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assesses investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. Maintains regular contact between monitoring visits with investigative sites to confirm protocol adherence and timely data recording. Conducts supervising tasks per the approved monitoring plan. Participates in the investigator payment process. Shares responsibility with other project team members on issues/findings resolution. Investigates and follows up on findings as applicable.
- Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites. Initiates clinical trial sites according to procedures to ensure protocol and regulatory and ICH GCP obligations, with recommendations as warranted. Performs trial close out and retrieval of trial materials.
- Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. 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 (e.g. Clinical Trial Management System).
- 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 and 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 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 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.
Knowledge, Skills and Abilities
- Proven clinical monitoring skills.
- Understanding of medical/therapeutic area knowledge and medical terminology.
- Strong understanding of ICH GCPs, applicable regulations and procedural documents.
- Well-developed critical thinking, including root cause analysis and problem solving.
- Ability to manage Risk Based Monitoring concepts and processes.
- Effective oral and written communication with medical personnel.
- Customer focus with good listening, attention to detail and ability to perceive underlying issues.
- Good organizational and time management skills.
- Interpersonal skills, flexibility and adaptability.
- Ability to work in a team or independently; good digital literacy (Microsoft Office) and ability to learn software.
- Good English language and grammar skills; good presentation skills.
- Australian citizenship or permanent residency required.
Perks
- Health & Wellbeing: Comprehensive benefits, wellness programs, and an Employee Assistance Program.
- Flexibility: Flexible work arrangements.
- Extra Leave: Generous leave policies, including 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 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. We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Our culture stands for integrity, intensity, involvement, and innovation.
Seniority level
- Not Applicable
Employment type
- Full-time
Job function
- Research and Science
Industries
- Pharmaceutical Manufacturing and Biotechnology Research
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📌 CRA II - Brisbane, Sydney, Adelaide, Perth
🏢 Thermo Fisher Scientific
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