Job Summary:
The Clinical Trial Associate (CTA) supports the operational execution of clinical trials from start-up through close-out. This role partners closely with Clinical Trial Leaders, study teams, CROs, and vendors to ensure trials are conducted efficiently, compliantly, and in alignment with program and company objectives.
Key Responsibilities
- Support clinical trial operations across all phases of the study lifecycle, ensuring milestones, deliverables, timelines, and budgets are met.
- Assist with CRO and vendor coordination and oversight, including tracking performance, deliverables, and documentation.
- Collect, track, and review investigator site regulatory documentation (e.g., FDA Form 1572, FDFs, CVs, medical licenses, and study-specific documents) for completeness and accuracy.
- Manage Trial Master File (TMF) filing, maintenance, reconciliation, and inspection readiness activities in compliance with ICH-GCP and company SOPs.
- Track and maintain essential study documentation, including CTA and budget status, site and vendor payments, monitoring visits and reports, SUSARs, CAPAs, and enrollment metrics.
- Coordinate study team, vendor, and site meetings, including scheduling, agenda preparation, minute-taking, and distribution.
- Ensure clinical trial management systems (company and/or CRO systems) are kept current in collaboration with the Clinical Trial Leader (CTL).
- Support study start-up, conduct, monitoring, and close-out activities to ensure protocol adherence and regulatory compliance.
- Assist with site monitoring activities, audit and inspection preparation, and participate in audit/inspection interviews as required.
- Support ordering, tracking, and distribution of investigational product and study supplies; assist with IRT oversight and drug inventory tracking.
- Provide operational and financial support, including purchase orders, contract setup, invoice processing, and tracking of study budgets.
- Assist with development, review, and maintenance of study documents (e.g., protocols, ICFs, CRFs, monitoring plans, manuals).
- Review study reports and operational metrics for accuracy and quality.
- Maintain study team lists, SUSAR distribution lists, databases, and departmental systems; support study team training activities.
- Support inspection readiness, compliance activities, clinical trial insurance processes, and patient recruitment material review.
- Collaborate cross-functionally with internal and external stakeholders to support successful trial execution.
- Perform additional duties as assigned.
- Experienced with using different eTMF systems (e.g., Veeva Vault, etc.)
- Accountable for the quality of own work. Receives clear instruction, guidance and direction from more senior level roles or even solves problems of low complexity independently by identifying and selecting solutions and by analyzing factual information.
- Contribute to harmonization of processes throughout Clinical Operations, use best practices to improve products or services
- Contribute to process improvement suggestions
- Take on additional tasks as assigned by management within a job discipline or specialized technical expertise
JOB SPECIFICATIONS:
- Ability to work in a matrix environment
- Experience working in a high-volume environment while maintaining both organization and the ability to prioritize tasks
- Good understanding of the responsibilities and needs of other functions in a clinical trial
- Reliable, conscientious, and confidential
- Strong interpersonal skills and ability to deal with people at all levels with sensitivity and tact as well as ability to collaborate across
- Some experience in oncology
- Experience in CRO oversight is preferred.
- Strong organization, documentation, and communication skills with an ability to
- Ability to travel based on assigned study needs, typically minimal travel required.
- Requires a bachelor’s degree in scientific field with no to some professional experienced or a substantial amount of professional experience in a clinical research-related position (1-2 years or equivalent) and/ or additional qualifications that also provides exposure to fundamental clinical research related skills & knowledge
- Good administrative and coordination skills
- Good communication skills – both verbal and written
- Good knowledge of medical and trial related terminology
- Good oral and written communication in English, other languages an asset
- Good organizational and problem-solving skills
- Good time and priority management, ability to work efficiently under pressure
- Good understanding of the policies and procedures of Clinical Operations and of ICH-GCP and current FDA regulations.
- Motivated, shows initiative, is proactive and able to work independently as well as in a team
- Strong computer skills including knowledge of MS Office™ (Excel™, Word™, PowerPoint™), Outlook, and TEAMS
- Familiar with Trial Master File handling, including use of different eTMF systems
- Willing to take on responsibility
