Clinical Trials Associate
Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
- Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
- Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.
- Our Commitment: Hiring the best and brightest minds to advance our world-class organization.
What You Will Experience:
- Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!
- Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!
- Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
- Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
- Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
- Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.
- Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce.
About the Role
The Clinical Trials Associate will support projects and studies across all indications within the Clinical Affairs department. Study-related tasks will be conducted in accordance with the protocol, Standard Operating Procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
To Make an Impact, You Will:
- Support Clinical Affairs, Data Management and CRAs in all activities during pre-study start-up, site initiation, site management, and study close-out.
- Assist with planning and organizing investigator and/or study site coordinator meetings and study progress communication (e.g., enrollment blasts, newsletters, etc.).
- Maintain, ship and track study documents, supplies, and study binders to study sites as needed
- Assist in the development, review and formatting of study specific training materials, source document templates, and study logs.
- Responsible for properly coding clinical trial documents in eTMF and/or study share-point site in compliance with Pulse Standard Operating Procedures (SOPs).
- Manage trial-related documents as required in the Trial Master File (TMF); review documents for completeness, accuracy and compliance with protocol and applicable regulations for studies that are not supported by a full service CRO.
- Assist in updating internal study-related trackers to support all studies (e.g., protocol deviations, adverse events, early termination, device accountability, study start-up time, and accrual goals across studies).
- Perform user acceptance testing (UAT) in the clinical database as specified by data management
- Participate in vendor and internal study team meetings.
- Support financial tasks for the study (e.g. investigator/institution/vendors payments, periodic quality control (QC) check on the clinical trials accrual workbook, and check compensation reports from the database financial module).
- Facilitate the preparation of meeting agendas and take meeting minutes for Clinical Affairs and Data Management meetings.
- Contribute to the development of standard operating procedures (SOPs) and best practices for clinical trials.
- Solve routine problems of limited scope and complexity following established policies and procedures.
- Seek assistance with more complex issues.
To Excel, You Will Bring:
- BS/BA degree in a science or related field required
- 2+ years’ experience working as a clinical trial associate (CTA) or in a similar role within the medical device or biotechnology industry is preferred.
- Working knowledge of GCPs, CTMS, Trial Master Files, ICH guidelines is required.
- Experience with MS Office Suite (Word, PowerPoint, Excel, Project) and Smartsheets.
- Excellent written and verbal communication skills.
- Experience with data management software and clinical trial databases.
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
- Ability to work independently as well as collaboratively in a team-oriented environment.
- Willingness to travel for job related activities if required (expected travel for this position is up to 10%).
- Ability to lift 10-15 pounds.
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $80k - $95k
Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation. To learn more about us, visit our website at www.pulsebiosciences.com.
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.
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