We develop technologies at the intersection of wearable devices, precision medicine, and life-saving therapeutics. Our first product aims to redefine treatment for the prevention of sudden cardiac death. Come join our growing team of medical device professionals if you are interested in making a real difference in patients’ lives and shaping the future of medtech in Silicon Valley.
Summary of Role
We are seeking a Senior Clinical Trials Assistant to join our growing Clinical team. This individual will be responsible for assisting the study teams with the initiation, planning, conduct and close-out of clinical trials sponsored by Element Science. The ideal candidate will have excellent people and organizational skills and a can-do attitude.
- Provide administrative support to the Clinical Affairs department in areas such as meeting coordination and logistics (study team meetings, Clinical Events Committees / Data Safety Monitoring Boards, Investigator Meetings, etc.), writing and distributing meeting minutes, filing, and archiving.
- Assist the Clinical Operations team in the initiation, conduct, and completion of Feasibility and Pivotal clinical trial activities.
- Create and maintain files for trial essential documents (e.g. Investigator Site File, Trial Master File (TMF)), including developing effective tracking systems for the documents. Assist in the distribution and collection of the essential documents.
- Periodically audit the TMF for completeness and accuracy.
- Provide accurate and timely updated site information as needed.
- Order non-investigational product study materials; if required, develop and maintain methods of tracking these materials.
- For trials utilizing paper Case Report Forms, process and track CRFs received by the Sponsor.
- Track site invoices and payments, requesting invoices from sites where required. Work with Clinical team to resolve payment discrepancies and/or issues.
- In support of monitoring visits, review TMF for completeness and required updates, compile documents and any necessary supplies; provide information to the assigned Monitor. Work with Monitor/CRA to resolve discrepancies, ensure completeness and accuracy of files.
- Other duties as assigned.
- Bachelor’s degree in nursing, life science, biomedical engineering, or related field preferred
- 2-3 years of experience in clinical research experience in the medical device industry, working specifically with regulatory documents and the trial master files
- Knowledge of ICH Good Clinical Practice Guidelines, FDA and European regulations pertaining to medical device clinical trials
- Strong interpersonal skills, the ability to work independently, and excellent organizations skills
- Proficient in PC applications such as MS Word, Excel, Access; able to quickly learn computer applications
- Use existing resources creatively and efficiently