Clinical Research Associate - San Jose, California

Clinical Research Associate - San Jose, California

We have an exciting opportunity for a Clinical Research Associate to join our growing team located in San Jose, California. The Clinical Research Associate is responsible for creating, implementing, and maintaining clinical trials; writing: protocols, case report forms, consent forms and clinical study reports.  In addition, this position will recruit and select investigators and ensures good clinical practices are followed.  The Clinical Research Associate will report to the Director of Clinical Affairs.

What you’ll do:

  • Design, implement, and monitor clinical trials.
  • Prepare integrated medical reports, and periodic reports.
  • Recruit and select new investigators.
  • Contract research organizations and vendors.
  • Design and write protocols.
  • Create informed consent forms.
  • Communicate trial dossier with IRB for approval.
  • Monitor investigator/clinical research site performance and adherence to protocols.
  • Address enrollment problems.
  • Write integrated medical reports and clinical sections of IDEs, and 510(k).
  • Prepare and present documents of scientific meetings.
  • Set up study centers and ensure each center has the necessary trial materials.
  • Visit the study centers throughout the trial on a regular basis.
  • Check the patient data in the case report forms (CRFs).
  • Validate and collect completed CRFs from hospitals and general practices.
  • Lead analysis of results.
  • Close down study centers upon completion of trial.
  • Write up study reports after analyses have been completed.
  • Ensure the conduct of trials is in compliance with the currently approved protocol/amendment.
  • Verify that the investigator followed the approved protocol and all GCP procedures.
  • Work with the relevant department(s) to ensure clinical trials comply with Venus Concept processes and standard operating procedures.

What you’ll need:

  • Bachelor or Master's degree in bio-clinical-science or similar degree - preferred
  • Minimum of 3-5 years of work experience in a clinical or clinical research setting, preferably as a clinical trial monitor with formal training in medical terminology
  • Demonstrated initiative and ability to work with minimal supervision
  • Organizational skills with keen attention to detail
  • Ability to multitask and handle multiple studies and/or clinical sites
  • Effective communication skills (written and verbal) with the ability to communicate effectively with clinical site staff and research physicians
  • Team player with a strong project focus and excellent interpersonal skills
  • Working knowledge of ICH/GCP guidelines, Federal regulations, medical terminology and clinical research processes
  • Basic computer skills and ability to learn and become proficient with appropriate software; working knowledge of Word, Excel, and PowerPoint
  • Position involves travels.

What you’ll be part of – our Venus Concept Culture:

Venus Concept believes in pushing boundaries while embracing creativity and innovation. Our employees are a critical part of our company’s performance and are at the core of its success. At Venus Concept, we rely on our employees, customers, and network of industry professionals around the world to continuously improve and Deliver the Promise. In order to do that, we ensure that everyone operates with the same values and vision.  At Venus Concept, we promise to give you Endless Opportunities, allow you to Foster Innovation and be part of Delivering a Best-In-Class Offering.

Venus Concept is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. Venus Concept is committed to accommodating persons with disabilities. Accommodations are available on request for qualified candidates during each stage of the recruitment process.

About Venus Concept
Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic technologies and reach in over 60 countries and 29 direct markets. Venus Concept focuses its product sale strategy on a subscription-based business model in North America and in its well-established direct global markets. Venus Concept’s product portfolio consists of aesthetic device platforms, including Venus Versa™, Venus Legacy™, Venus Velocity™, Venus Fiore™, Venus Viva™, Venus Freeze Plus™, and Venus Bliss™. Venus Concept’s hair restoration division includes NeoGraft®, an automated hair restoration system that facilitates the harvesting of follicles during a FUE process and the ARTAS® and ARTAS iX™ Robotic Hair Restoration Systems, which harvests follicular units directly from the scalp and create recipient implant sites using proprietary algorithms.  The company has expanded its subscription platform and is now selling its devices in over 60 countries, including 29 with direct offices. Venus Concept now has over 500 global employees whose customer-centric approach has supported the company's rapid growth. For more information, please visit www.venusconcept.com.

Submit your resume/CV

Thank you for your interest in joining the Venus Concept team. Please fill out the form below and we will get in touch if it's the right match.

ALL FIELDS ARE MANDATORY