Location: New York, NY
Reports to: Director, Clinical Operations
Sr. / Clinical Trial Assistant
Axsome Therapeutics is currently searching for a Clinical Trial Associate (CTA) to lead one, or more, of our clinical studies. We are a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders. By focusing on this therapeutic area, Axsome is addressing growing markets where current treatment options are limited or inadequate. Axsome has a balanced portfolio of clinical development stage as well as research stage products. Axsome is located in New York City, New York.
The CTA is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. This role will provides support to the study trial manager, the field based CRAs, and the clinical study sites. This role will be a key study team member responsible for multiple clinical trials (all phases) and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines.
- Create and maintain study trackers (e.g., contact lists, study status trackers, enrollment).
- Ensure accurate and up to date information in clinical trial management system (CTMS).
- Review and maintain documents in the Trial Master File (TMF).
- Assist clinical team during all phases of clinical study activities (feasibility, start-up, maintenance, and close-out).
- Collect and review essential regulatory documents prior to site initiation/study drug release.
- Submission and tracking of documents to central IRB.
- Distribute materials to study sites, as directed.
- Participate in study team and vendor meetings. Schedule meetings and draft meeting minutes/distribute final minutes, as needed.
- Assist the project team in preparation and distribution of study documents (e.g, consent form, study reference manual, regulatory binder, patient recruitment material, and newsletters).
- Support field-based clinical study monitors.
- Assist with quality review of clinical data including issuing and/or closing queries, as needed.
- Assist project team with Investigator Meeting coordination and preparation and draft meeting minutes.
- All other duties as required.
- Bachelor degree required. Preference to candidates with a life science or nursing degree.
Must be able to work in the NYC or San Francisco office.
- At least 1 year experience in a biotech/pharmaceutical company or clinical research organization (CRO). Preference to candidates with prior CTA or in-house CRA experience.
- Must have good organization skills, be a team player, function independently and be able to interact comfortably with company personnel as well as vendors and investigational sites.
- Computer proficiency, GCP, EDC and basic clinical research terminology knowledge required.
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Excellent team player; willingness and ability to fill functional gaps in a small but growing organization.
- Preference to energetic candidates with a desire to think “outside the box”.