Senior Clinical Research Associate

Location
Hayward, CA, United States
Posted
Apr 16, 2021
Ref
1046
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
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:

We are seeking Senior Clinical Research Associates for multiple regions throughout the United States! The Senior Clinical Research Associate is responsible for managing and monitoring activities that will lead to successful execution of clinical studies. This position will monitor patient recruitment, data and study related information related to clinical sites and study participation. Ensures that duties are performed 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).

Essential Duties and Responsibilities:

  • Provides case support to research sites across multiple studies.
  • Prepare and develop project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries.
  • Coordinate review of data listings and preparation of interim and final clinical study reports.
  • Responsible for monitoring clinical studies, which includes the review of case report forms (CRFs) or electronic data capture (EDC), and source documentation to ensure adherence to the protocol and scientific validity of the data.
  • Responsible for developing study specific monitoring tools and other related documents.
  • Delivers high quality written monitoring reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.
  • Responsible for reviewing and approving essential regulatory documents across multiple studies.
  • Assists the project team in developing study metrics to ensure the efficient execution of a clinical trial.
  • May support submission of trials to IRB/IEC and regulatory authorities.
  • Ensures adherence to study timeline across multiple studies.
  • Coaches and mentors Clinical Research Associates (CRAs) in development and training.
  • Maintains strong working knowledge of protocols and product development across multiple studies.
  • Demonstrates ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team.
  • Demonstrates an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations.
  • Verifies the rights and well-being of study subjects are protected and verifies that written informed consent was obtained before each subject’s participation in the study.
  • Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
  • Ensure compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies.
  • Manage Protocol Deviation documentation, tracking, and escalation.
  • Participates in site audits, as requested.


Education and Experience:

  • Bachelor's degree (BA/BS) with 5 years of relevant experience or Master’s degree with 3 years relevant experience. Relevant experience must be in clinical research as a monitor in the pharmaceutical, biotechnology or CRO industry; Clinical research or life science degree preferred.
  • Must have 2 years of experience in medical device.
  • Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred.


Skills, Abilities, and Other Requirements:
  • 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.
  • Working knowledge of FDA, European Regulatory and EC procedures, as applicable.
  • Exhibits a strong knowledge base of medical terminology and pathophysiology.
  • 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.