About the Role
The Senior Clinical Trial Associate will play a key role in managing clinical trial activities, including protocol adherence, regulatory documentation, and coordination across cross-functional teams to advance study timelines and ensure quality outcomes.
Responsibilities
- Oversee day-to-day operations of assigned clinical trials
- Ensure compliance with Good Clinical Practice and regulatory requirements
- Support the development and review of study protocols and related documents
- Coordinate with investigators and clinical sites to maintain trial progress
- Manage essential regulatory documentation and submissions
- Assist in the preparation of clinical trial agreements and site initiation materials
- Track and report on clinical study milestones and deliverables
- Collaborate with cross-functional teams including data management and safety
- Contribute to the development of monitoring plans and visit reports
- Participate in vendor selection and oversight activities
- Review source data and case report forms for accuracy and completeness
- Support audit and inspection readiness efforts
- Maintain trial master files in accordance with company standards
- Identify and escalate trial-related risks and issues
- Ensure proper documentation of protocol deviations
- Assist in the training of site personnel
- Track investigational product accountability
- Support interim and final study reporting
- Facilitate communication between internal teams and external partners
- Contribute to process improvement initiatives in clinical operations
- Ensure timely resolution of monitoring findings
- Participate in investigator meetings and conference calls
- Assist in the development of study-specific tools and templates
- Maintain up-to-date knowledge of clinical regulations and guidelines
- Support global trial execution with attention to regional requirements
Compensation
Competitive hourly rate commensurate with experience
Work Arrangement
Hybrid work model with partial remote flexibility
Team
Collaborative clinical operations team within a growing biotechnology organization
Why Join Us
- Opportunity to contribute to innovative microbiome-based therapies
- Work in a science-driven, collaborative environment
- Engage in meaningful clinical development projects
- Be part of a mission-focused organization advancing human health
Application Process
- Submit resume and cover letter through company careers portal
- Applications reviewed on a rolling basis
- Shortlisted candidates will be contacted for interviews
- Final candidates may undergo reference and background checks
Not available for this contract position
