Clinical Trials Associate
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 Associate will support Clinical Affairs with study execution and provide logistical support in managing the full scope of clinical trial(s), track study progress in CTMS and oversee the set up and maintenance of the electronic trial master file (TMF) in compliance with SOPs, regulations, and ICH/GCP guidelines.Essential Duties and Responsibilities:
- Support Clinical Affairs Management and CRAs in all activities during pre-study start-up, site initiation, site management, and study close-out.
- Maintains, ships and tracks study documents, supplies, and study binders in compliance with Pulse Standard Operating Procedures (SOPs) and study-specific processes
- Assist in the development, review and formatting of study specific training materials, source document templates and newsletters
- Develop study-specific trial master file (TMF) plan(s) and manage/oversee collecting, tracking, and archiving of Essential Documents throughout the life of the study
- Responsible for properly coding clinical trial documents in eTMF
- Maintain and update study trackers/metrics on an on-going basis (e.g., protocol deviations, adverse events, early termination, device accountability, study start-up time, accrual goals, and required resources across studies)
- Accurately updates clinical systems with milestones within project timelines
- Maintains screening & enrollment tracking database to assist management with subject recruitment strategies and projections
- May conduct Informed Consent Form (ICF) review
- May participate in clinical data and photographic image reviews
- Facilitate the preparation of meeting agendas and take meeting minutes for clinical team meetings
- Assistance with planning and organizing study site coordinator meetings and study progress communication (e.g., enrollment blasts, newsletters, etc.)
- Follows up with sites for trial invoices and ensures Clinical Trial Management System (CTMS) is accurately updated to allow the timely processing of Investigator Payments.
- Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives.
- Solves routine problems of limited scope and complexity following established policies and procedures.
- Seeks assistance for more complex issues.
Education and Experience:
- Minimum BS/BA degree.
- 2+ years’ experience directing supporting clinical research.
Skills, Abilities, and Other Requirements:
- Working knowledge of GCPs, CTMS, Trial Master Files, ICH guidelines is required.
- Read, write, and speak fluent English; fluent in host country language required
- Experience with MS Office Suite (Word, PowerPoint, Excel, Project) and Smartsheets
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
- Willingness to travel for job related activities if required (expected travel for this position is up to 15%).
- Ability to lift 10-15 pounds
Pulse Biosciences currently maintains a policy requiring all United States-based employees to be fully vaccinated against COVID-19. In accordance with applicable law, Pulse Biosciences will consider reasonable accommodations to employees who qualify as required under federal, state and local law where it is not an undue hardship to the company to do so.
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.
LOCAL CANDIDATES ONLY
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.