Location: Redwood City, CA
Lassen Therapeutics is a therapeutic antibody discovery and development company dedicated to the identification of novel medicines for serious unmet medical needs. We are currently recruiting for a highly organized and detail-oriented Senior Clinical Research Associate to join us and assist with the execution of our Phase 1/2 clinical trials. In this role, you will have a unique opportunity to help build our therapeutic pipeline of novel antibody-based medicines with applications in tissue fibrosis, inflammation and oncology.
Responsibilities:
- Support the clinical operations team in the overall management of studies, including planning, execution, and closeout of outsourced clinical trials.
- Assist our clinical operations team with monitoring oversight activities. This could include attending monitoring visits, review of monitoring reports, tracking of site visits, and assisting with contract review.
- Assist the clinical operations team with external vendor management. This could include participating in the selection process, providing ongoing oversight of selected vendors, and escalation of issues.
- Assist with preparation of all external and internal documentation for assigned trials to ensure it’s completed in accordance with GCP regulatory requirements and consistent with the study protocol. This includes the ability to draft, review and finalize study-specific plans.
- Assist with reviewing informed consent forms and other Trial Master File (TMF) documents, ensuring that all regulatory requirements are met.
- Manage internal study meetings inclusive of setting agendas, recording and distributing minutes.
- Organize and prepare study files related to study tracking and reporting and submit them to the electronic Trial Master File within established guidelines, maintain up-to-date documentation for all study sites globally.
- Participate in data review, identification of discrepancies, and query management
- Prepare training materials and supporting trainings.
- Maintain, track and oversee site access requests and site supplies.
Requirements:
- Bachelor’s degree with a preferred focus on a life science or healthcare related field.
- 4+ years of clinical trial experience.
- 2+ years of experience working directly for a sponsor.
- Working knowledge of ICH GCP regulations and clinical protocols.
- Strong interpersonal, organizational, and multi-tasking skills.
- Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency.
- Able to perform in a fast-paced, dynamic, constantly evolving environment.
- Excellent teamwork skills and the ability to understand and respond to the needs of multiple disciplines.
This is an onsite position with up to 20% overnight travel required to various site locations, as needed.