What are the responsibilities and job description for the Senior Clinical Trial Associate position at Expedition Therapeutics?
About the Company:
We are an innovative, science-driven biotechnology company developing novel therapeutics for COPD and other serious neutrophilic inflammatory diseases. Our team combines deep discovery and development expertise with a nimble, collaborative culture to advance cutting-edge programs from concept through clinical proof-of-mechanism.
Position Summary:
Reporting to the Vice President of Clinical Operations, the Senior Clinical Trial Associate (CTA) plays a key role in supporting the planning, execution, and operational management of clinical trials. This position is responsible for ensuring high-quality trial execution in compliance with applicable regulatory requirements and ICH/GCP standards.
The ideal candidate is highly organized, detail-oriented, and comfortable working in a fast-paced, hands-on, small-company environment. This role requires strong cross-functional collaboration and the ability to manage multiple priorities effectively.
Key Responsibilities & Trial Planning and Start-Up:
- Assist in the development and review of trial-related documents, including informed consent forms, study manuals, and training materials.
- Coordinate with cross-functional teams to ensure timely availability of investigational products, trial supplies, and study materials.
- Support investigational site selection and qualification, including review of site feasibility questionnaires and evaluation reports.
- Assist with site initiation activities, including preparation and review of site initiation and training materials.
Trial Execution and Operations:
- Support the implementation and ongoing management of clinical trials in accordance with study protocols, SOPs, and regulatory requirements.
- Track study timelines, milestones, and deliverables to ensure adherence to project plans.
- Support meeting logistics, including scheduling, agenda preparation, minutes, and action item tracking.
- Assist with trial budget tracking, invoice review, and financial reconciliation.
- Support clinical data review and reconciliation, identifying and resolving discrepancies in collaboration with internal teams and vendors.
- Contribute to user acceptance testing (UAT) of clinical systems, including IRT, eCOA, and EDC.
- Create and maintain internal study folders and documentation on company share drives.
- Assist in the development of study materials, presentations, dashboards, and reports.
- Support and maintain tracking tools for key metrics, including IRB/EC submissions, site activation, budget and CTA approvals, and patient enrollment.
Quality and Compliance:
- Support quality control and maintenance of the Trial Master File (TMF), ensuring completeness, accuracy, and timely documentation of essential documents.
- Stay current on applicable regulations, guidelines, and industry best practices related to clinical trial conduct.
- Assist in the review and implementation of Clinical Development operating procedures and process improvements.
Qualifications:
- Bachelor's degree in a scientific or healthcare-related field.
- At least 3 or more years of experience in clinical research, preferably as a Clinical Trial Associate or in a similar role.
- Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
- Familiarity with clinical trial protocols, informed consent processes, and data collection methods.
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills.
- Proficiency in using clinical trial management systems and electronic data capture systems.
- Ability to work independently and collaboratively in a team environment.
Other Knowledge and Skills:
- Demonstrated ability to build strong working relationships across functions and disciplines.
- Comfortable functioning at a high level as both an individual contributor and a team member.
- Strong interpersonal skills with the ability to communicate effectively and professionally in a collaborative setting.
Why Join Us:
- Opportunity to make a direct impact on programs shaping the future of respiratory disease treatment.
- Collaborative, entrepreneurial environment with direct visibility to leadership and investors.
- Competitive salary, equity participation, and full benefits package.