We're Hiring!
Clinical Trial Associate/Senior Clinical Trial Associate
Lighthouse Pharmaceuticals Inc. is searching for a CTA/Sr. CTA to join our Clinical Operations team to participate in and contribute to the development of new therapies for the treatment of highly complex neurological conditions. This position will support LHP588-201 Phase 2 Study for patients with P.g. positive Alzheimer’s Disease. For more information, please visit https://clinicaltrials.gov/study/NCT06847321.
This position is 100% home-based and none or minimum travel requirement (less than 10%). We offer a generous benefits packet, a great work environment, mentoring and opportunities for professional growth and development.
Department:
Clinical Operations
Reports To:
Clinical Operations Manager/Director (or equivalent)
Position Summary
The Senior Clinical Trial Associate (Sr. CTA) provides critical operational and administrative support to the Clinical Operations team to ensure the successful planning, execution, and maintenance of clinical trials. This role serves as a primary site liaison for the collection and maintenance of essential regulatory documents, supports Clinical Research Associates (CRAs) with monitoring preparation, and manages key study tracking and documentation activities. The Sr. CTA will thrive in a small, fast-paced biotech environment and work collaboratively across internal and external stakeholders.
Key Responsibilities
Site Start-Up and Essential Document Management
- Serve as primary contact for investigative sites for the collection, review, and tracking of essential regulatory documents during study start-up and throughout the trial.
- Maintain and update the Trial Master File (TMF) in compliance with ICH-GCP, company SOPs, and study-specific requirements.
- Track status of site regulatory submissions, IRB/EC approvals, and site activation readiness.
Monitoring Support
- Assist CRAs with pre-monitoring preparation, including assembling site files, study reference materials, and visit-specific documentation.
- Support CRAs in follow-up of outstanding action items, queries, and site correspondence
Send information to jobs@lighthousepharma.com