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About the Role

CTI Clinical Trial and Consulting Services is a global, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patients. We support clinical research from drug concept to commercialization, collaborating with pharmaceutical, biotechnology, and medical device firms.

Responsibilities

• Serve as the main CTI contact for assigned study sites.
• Conduct site visits (pre-study, site initiation, interim monitoring, and close-out) and complete deliverables within timelines and regulatory requirements.
• Assist with or oversee study start-up activities, including feasibility, pre-study activities, and site selection.
• Collect, review, and track essential/regulatory documents.
• Participate in and complete all general and study-specific training.
• Participate in investigator, client, and project team meetings, potentially including presentations.
• Create and implement subject enrollment strategies for assigned study sites.
• Ensure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials.
• Perform site management activities and provide ongoing updates of site status to the Clinical Project Manager.
• Conduct remote monitoring and complete related activities in accordance with the study-specific Monitoring Plan.
• Utilize systems and reports to track subject status, CRF retrieval/SDV, regulatory documents, and IP.
• Assist with project-specific activities as a member of the Project Team.
• Participate in the development of CRFs and other study-related documents.
• Perform translation, customization, and review of Patient Information sheets, Informed Consent forms, protocol synopses, and other study applicable documents.
• Provide support to the Regulatory Affairs Study Start-up Team in preparing or revising documentation for submission to Ethics Committees, Regulatory Authorities, Competent Authorities, or Institutions Administration Boards, and follow up on the evaluation process until approval.
• Provide regular updates to the Sponsor/Client.
• Support or oversee contract negotiation with study sites, Investigator payments, and tracking of site payments.
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans.
• Identify and anticipate site issues and implement corrective and preventive actions or escalate as appropriate.
• Liaise with Clinical Data Management for data cleaning activities.
• Serve as a mentor/trainer for CRAs, potentially including conducting training/assessment visits.
• Function in the role of Lead CRA for assigned project(s).
• Identify and propose process improvements.
• Provide therapeutic area expertise to team members.

Requirements

• At least 3 years of clinical trial monitoring experience or equivalent.
• Fluent in English.
• Previous experience in conducting clinical research studies in a hospital setting, pharmaceutical company, or as a CRA.
• Fully eligible to work in Australia.
• CTI does not provide VISA Sponsorship.

Location

• Sydney

Work Type

• Hybrid

Experience Level

• 3+ years

Education Level

• Bachelor's Degree or higher in allied health field (nursing, pharmacy, health/natural science)
• RN with Associate's Degree
• 3-year Nursing Diploma with at least 2 years clinical nursing experience
• Equivalent experience

Benefits

• Structured mentoring program
• Leadership courses
• Ongoing education and training
• Tuition reimbursement
• Dedicated training department
• Generous health benefits
• Vacation packages
• Hybrid work from home opportunities
• Paid parental leave
• CTI Cares program

About the Company

• CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
• We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
• CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.