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Clinical Research Associate

NeoTract


Location:
Pleasanton, California
Date:
09/25/2017
2017-09-252017-10-25
Job Status:
Full Time
Categories:
  • Clinical Operations
NeoTract
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Job Details

About NeoTract 

NeoTract is a medical device company featuring a revolutionary technology called The UroLift® System.  The UroLift® System treats BPH (benign prostatic hyperplasia) by lifting and holding the enlarged prostate tissue thus unblocking the urethra.  It is the only BPH procedure that does not require cutting, heating, or removal of the prostate tissue.  Over 25,000 patients have been treated with UroLift®, and we are currently seeking exceptional talent to grow our organization.

About the Position

The Clinical Research Associate (CRA) monitors US and international clinical sites.  As an integral member of the Clinical team, this position manages and oversees study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs). This position requires strong attention to detail, excellent organizational skills, and a strong desire to learn clinical research processes continuously.

Job Responsibilities

  • Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
  • Conduct regular onsite initiation, interim, and close-out monitoring visits.
  • Ensure timely completion of reports.
  • Support the Clinical team by participating in clinical trial projects and various improvement initiatives.
  • Recognize potential obstacles and work to resolve them within set timelines.
  • Maintain compliant trial master clinical files and ensure each site is maintaining its Regulatory Binder as required.
  • Monitor emerging industry and regulatory trends to help integrate new requirements into department procedures.
  • Complete projects and tasks consistent with company objectives.
  • Attend relevant symposiums, meetings, and conferences.
  • Support safety monitoring and CEC processes.
  • Participate in department systems and development initiatives, including related trainings.
  • Perform other duties as assigned.
  • Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Qualifications

  • BA/BS degree or RN; or equivalent experience.
  • At least 3 years of experience in clinical research as a CRA preferred.
  • Interim monitoring experience essential, medical device experience preferred.
  • Experience in urological therapeutic area preferred.
  • Ability to perform well-defined procedures initially with supervision, and after direction is provided, work independently.
  • Proficient in Microsoft Word, Excel, and Access; and the technical wherewithal and inclination to become quickly proficient in a variety of other software.
  • Strong knowledge of US and international clinical regulations.  
  • Ability to make independent decisions and take responsibility for own actions within a fast-paced environment.
  • Ability and willingness to travel approximately 50% of the time.
  • Valid driver’s license issued by residing state and good driving record.
  • Overnight travel will be required. 
  • International travel may be required.
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