Clinical Trial Coordinator - Home based across Sydney, Brisbane, Adelaide or Perth
Thermo Fisher Scientific
- Melbourne, VIC
- Permanent
- Full-time
- Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
- Provides system support (i.e. CTMS, Activate & eTMF) and ensures system databases are always current.
- Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
- May support scheduling of client and/or internal meetings.
- Provide administrative support including but not limited to, printing documents for site files, arranging couriers to and from sites, managing returns of non-investigational project specific supplies if required.
- May review and track of local regulatory documents.
- Maintains vendor trackers.
- Supports start-up team in Regulatory submissions.
- Works directly with sites to obtain documents related to site selection.
- Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
- May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.
- Bachelor's degree is the minimum requirement, preferably in the area of health/medical science or nursing.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
- Ability to work in a team or independently as required.
- Flexibility to reprioritize workload to meet changing project timelines.
- Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs.
- Good English language and grammar skills.
- Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
- Effective oral and written communication skills.
- Crucial judgment and decision-making skills.
- Capable of accurately following project work instructions.
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)