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Clinical Research Associate With Cardiac Device (Remote/Field)

Burligame, CA

Posted: 08/19/2022 Job Number: 21520628

Job Description

Project Description:
  • Our client is seeking to hire a Clinical Research Associate (CRA) or Senior Clinical Research Associate to be based in Burlingame, CA or remotely anywhere in the United States outside of Colorado.
  • As a (Lead) CRA you will work on Medical Device Clinical trials, traveling 40-70% of the time within the US, supporting the planned clinical trials of the J-valve.
  • CRA who can manage study activity -- from site selection and start-up to close-out -- with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals.
  • As a key contributor to the Clinical Affairs team, this position develops and assesses SOPs and other processes for efficiency and compliance.
  • As a CRA, you work with clinical personnel and field engineers, monitoring sites and managing the clinical trial team. In addition, you will.
  • Communicate with investigators, colleagues, and vendors ensuring clinical quality and compliance.
  • Support various phases of clinical studies (i.E., study planning, monitoring, data integrity, closeout, etc.).
  • Support the development of clinical study plans, product development, presentations, study documents, contracts, and design of case report forms.
  • Identify noncompliance with trial protocol and implement preventative and corrective actions.
  • Lead review of clinical data for accuracy and escalate issues to the Director of Clinical Affairs and the Chief Operating Officer when necessary.
  • Develop and implement enrollment and recruitment strategies.
  • Review monitoring visit reports and track resolution of action items.
  • In addition, the Lead CRA will provide oversight of sites (from the perspective of the sponsor) and also mentor junior team members.
  • The Lead CRA oversees contract research organization personnel, site activities, and vendor performance.
  • The Lead CRA also engages study personnel with demonstrations and guidance on how to deploy the device, by request.

Required Skills:
  • Bachelor's Degree in one of the life sciences or health care background (RPh, RN, etc.) is required.
  • Master's Nursing Degree (MSN) or Certification through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) is preferred.
  • 3+ years relevant work experience in a clinical study operations role is required.
  • 2+ years Clinical Research Associate (CRA) clinical research monitoring / site management experience; or equivalent combination of education, training, and experience preferred.
  • Working knowledge of GCP/ICH guidelines, federal and local regulations required.
  • build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in clinical functions.
  • Dedicated achievers.
  • Employees who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • For those with a keen interest in medical device research, this position requires the ability to be detail-oriented, organized, and productive.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com


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Bridget Burns

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