Senior Clinical Research Associate I
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Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt 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.Summarized Purpose:Performs and coordinates different aspects of the clinical monitoring and site management process.
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
Manages procedures and guidelines from different sponsors and/or supervising environments (i.E. FSO, FSP, Government, etc.).
Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
Ensures audit readiness.
Develops collaborative relationships with investigational sites.
Detailed tasks and responsibilities assigned to role are outlined in the task matrix.Location InformationThis is a home-based position and preferably based in Western/Southern AustraliaKey responsibilitiesMonitors 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.
May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
Conducts supervising tasks in accordance with the approved monitoring plan.
Participates in the investigator
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