Oncology Clinical Research Assistant Early Phase Trials 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, like protecting the environment, making sure our food is protected or helping find cures for cancer.

About the Role
Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You'll Do
- Monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure 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. Assess 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 follow all issues through to resolution.



Maintains regular contact between monitoring visits with investigative sites to confirm protocol compliance and data recording timely.
- 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.
- Provides updates on potential trends across multiple sites and discusses strategies for their management to the Clinical Team Manager (CTM).
- Participates in investigator meetings as necessary.
- Identifies potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites.
- Initiates clinical trial sites according to the relevant procedures to ensure protocol compliance and regulatory and ICH GCP obligations.
- Ensures trial close out and retrieval of trial materials.
- Ensures essential documents are complete and in place, according to ICH‑GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members.
- Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements & share solutions.




- Performs additional tasks as assigned by CTM or Clinical Manager of CRAs (CM‑CRA) such as trip report review, newsletter creation, lead CRA team calls etc.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM).
- Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
- 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 federal regulatory requirements/audits.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Education
- Bachelor's degree in a life science 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 3+ years as a clinical research monitor).
- In some cases equivalency of education, training and directly related experience will be considered sufficient. Knowledge, Skills, Abilities
- Effective clinical monitoring skills.
- Excellent understanding and demonstrated application of FDA guidelines, 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.
- Manages Risk Based Monitoring concepts and processes.
- Ability to mentor and train

📌 Oncology Clinical Research Assistant (Brisbane)
🏢 Icon Oncology Group
📍 Brisbane