Clinical Trials Assistant
Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.
We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. We take pride in hiring the best and brightest minds to our world-class company. Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture.
The Clinical Trial Assistant (CTA) will provide logistical and administrative support to the Clinical Research team. This position requires basic knowledge of clinical regulatory requirements and clinical trials, excellent organizational skills, and the ability to perform at high levels in a fast-paced, dynamic environment.
Essential Duties and Responsibilities
- Assist in generation of study start up materials and support feasibility study activities.
- Participate in the design and implementation of case report forms, CRF and completion guidelines, and database testing.
- Maintain clinical study and subject schedules; Collaborate with team lead on subject tracking to ensure protocol compliance.
- Maintain and organize clinical study documents and reference materials related to the indication.
- Able to review data within the EDC and photography management systems, perform and collate data downloads, reports, and prepare summaries of data extractions for review.
- Collaborate with CRAs and Data Management on data cleaning, tracking and data analysis quality.
- Assist team members with designated administrative tasks in support of clinical trial execution and management.
- Perform study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete with applicable local regulatory requirements and ICH/GCP guidelines.
- Assist in the production of slides for project, departmental, sponsor and/or business development presentations.
- Actively order and maintain ancillary clinical study supplies required for conduct of clinical trials.
- Assist with preparation, shipping, handling, distribution, and/or accountability of clinical trial supplies.
- Follow up with sites for trial invoices and ensure CTMS is accurately updated to allow the timely processing of Investigator Payments.
- Contribute to the development of clinical trial management best practice processes and SOPs.
- Maintain up-to-date knowledge of current regulations and guidelines to ensure compliance.
- Solve routine problems of limited scope and complexity following established policies and procedures.
- Work collaboratively with team to solve more complex issues.
- May perform other duties as assigned.
Education and Experience
- Bachelor's degree or equivalent combination of education and related work experience.
- One or more years medical device experience, experience in a health science or engineering field.
Skills, Abilities, and Other Requirements
- Highly proficient in Microsoft Office applications of Word, Excel, and PowerPoint. Knowledge of relational databases, intermediate statistical analysis, or coding platforms, such as Matlab, is a plus.
- Basic knowledge of clinical regulations and guidance including GCPs, and ICH guidelines.
- Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Positive attitude; Able to work under tight timelines.
- Ability to travel up to 15% of the time.
- Ability to lift 10-15 pounds.
Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at www.pulsebiosciences.com.
At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce. We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.