Expedition Therapeutics
Senior Clinical Trial Associate
Expedition Therapeutics, San Diego, California, United States, 92189
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 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.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Science
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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 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.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Science
#J-18808-Ljbffr