Location: New York, NY
Reports to: Director, Clinical Operations
Clinical Trials Assistant
Axsome Therapeutics is currently searching for a Clinical Trials Assistant. We are a biopharmaceutical company developing novel therapies for the treatment of pain and other neurological diseases. 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 Clinical Trials Assistant is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. The Clinical Trial Assistant provides a key support function to the clinical operations team. Under general guidance from Clinical Operations, you will support the Clinical team responsible for management of multiple clinical trials (all phases), and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines.
- Assist with 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.
- Create and maintain study trackers (e.g., contact lists, study status trackers, enrollment).
- Maintain up to date information in CTMS.
- Participate in creation and user acceptance testing (UAT) for EDC/IWRS and other systems, as required.
- Assist the project team in preparation and distribution of study documents (e.g, consent form, study reference manual, regulatory binder, and newsletters).
- Support field-based clinical study monitors.
- Participate in study team and vendor meetings. Schedule meetings and draft meeting minutes/distribute final minutes, as needed.
- Assist project team with Investigator Meeting coordination and preparation and draft meeting minutes.
- Maintenance of the electronic TMF.
- Assist with quality and validity of clinical trial data.
- Provide clerical support and administrative activities for project team (e.g., shipment of study materials, proofreading and editing correspondence).
- All other duties as required.
- BS degree in a biological or physical life science or a nursing degree or equivalent preferred.
- 1-year experience in a clinical department of a biotech/pharmaceutical company or completion of Clinical Research Certificate preferred.
- 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.
- Knowledge of clinical terminology required.
- Computer proficiency and GCP knowledge required.
- Willingness to travel.
- 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.
Must establish professional relationships with vendors, clinical investigators, opinion leaders, consultants, clinical research organizations, professional societies, etc.