Clinical Research Associate
Pulse Biosciences Hayward, CA
- Expired: over a month ago. Applications are no longer accepted.
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.Position Summary:
The Clinical Research Associates (CRA) is responsible for assigned aspects of clinical monitoring and site management in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP). Site visits are conducted to assess protocol and regulatory compliance, data reliability, and the proper care and treatment of study subjects.Essential Duties and Responsibilities:
- Provides case support to research sites across multiple studies.
- Prepare for, plan, organize and conduct site qualification, site initiation, interim and close-out visits.
- Completes monitoring reports within two weeks of visit date.
- Train site staff on therapeutic areas, protocol requirements, study device, proper source documentation and case report form completion.
- Order, track, and manage investigational product (IP) and trial materials as needed.
- Oversee and document IP dispensing, inventory and reconciliation.
- Protect subjects’ confidentiality and verify IP was dispensed and administered according to protocol.
- Ensure compliance with the patient-informed consent process.
- Ensure compliance in reporting adverse events/serious adverse events according to the study protocol and applicable regulatory agencies.
- Ensure compliance with Standard Operating Procedures (SOPs) and local regulations, and ICH, and GCP guidelines.
- Responsible for the creation and maintenance of the trial master file, regulatory binder, source documents, and photography slides.
- Regularly update project tracking tools and systems.
- Support electronic data capture (EDC) user acceptance testing and training as needed.
- Ensure timely resolution of all data queries remotely or at investigator site.
- Perform source data verification against CRF/EDC entries in compliance with the Monitoring Plan.
- Responsible for reviewing data and documents related to study endpoints.
- Assist with study report completion.
- Create adjudication packets under the supervision of study management.
- Bachelor's degree (BA/BS) with minimum 1+ years of experience directly supporting clinical research or relevant experience in medical/scientific area.
Skills, Abilities, and Other Requirements:
- Demonstrates working knowledge of GCP, ICH guidelines, ISO Standards, and FDA regulations.
- Proficient in using EDC and CTMS systems.
- Proficient in Acrobat Adobe and the ability to quickly become proficient in a variety of other computer software programs.
- Proficient knowledge and skill in Microsoft Office Suite applications, as well as Adobe Acrobat, with the ability to quickly become proficient in a variety of other computer software programs.
- Experience in monitoring clinical trials is desirable.
- Excellent oral and written communication skills with strong presentation skills.
- Clear and systematic thinking that demonstrates good judgment and problem-solving competencies. Excellent critical thinking analytical skills.
- Strong organizational skills with the ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
- Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
- Flexibility in work hours and readiness to travel. Travel may be up to 75%. Overnight and/or international travel may be required.
- 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.
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