Pulse Biosciences, Inc.

Senior Clinical Research Associate, Cardiac Surgical Products

Pulse Biosciences, Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • Provides case support to research sites across multiple studies with minimal guidance.
  • Prepares and develops project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries.
  • Coordinates review of data listings and preparation of interim and final clinical study reports.
  • Responsible for monitoring clinical studies, which includes review of case report forms (CRFs) both paper and/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 the timelines of SOPs and monitoring plans.
  • Ensures that all missing action items (MAIs) from monitoring visits are closed within the timelines of 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.
  • Oversees clinical data to ensure queries are closed within stipulated timelines of study goals
  • Provides clinical support for submission of trials to IRB/IEC and regulatory authorities.
  • Ensures adherence to study timeline across multiple studies.
  • Coaches and mentors other 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.
  • May perform other duties as assigned.

Requirements

  • BS/BA degree or equivalent experience.
  • 5+ years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
  • Must have at least 3 years of CRA experience in device or biotech clinical trials.
  • Cardiovascular device experience preferred.
  • Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred.
  • Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and Smartsheet; and the ability to quickly become proficient in a variety of other computer software programs.
  • Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting.
  • Proficient in using EDC and CTMS systems.
  • Working knowledge of FDA, European Regulatory and EC procedures, as applicable.
  • Excellent oral, 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 30%-50% of the time, overnight and/or international travel may be required.
  • Ability to lift 10-15 pounds.
Benefits
  • A variety of health insurance plans and supplemental insurance options
  • 401k retirement savings plan
  • Paid time off
  • Paid holidays
  • Flexible work schedule
  • Wellness program, including onsite gym and mindfulness classes
  • Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchcase report forms (CRFs)electronic data capture (EDC)monitoring toolsregulatory document reviewadverse event reportingprotocol deviation documentationInvestigational Product accountabilityclinical trial metricsGood Clinical Practices (GCP)
Soft Skills
communication skillsorganizational skillsproblem-solvingcritical thinkingteamworkflexibilityjudgmentinitiativementoringcoaching
Certifications
BS/BA degreeCertified Clinical Research Associate (CCRA)Certified Clinical Research Coordinator (CCRP)