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Job detail

Coordinator, Clinical Affairs

JENAVALVE TECHNOLOGY INC

Employer page
#Quality Control#Clinical Studies#Regulatory Binders#GDP#Clinical Affairs#US Regulations#Clinical Research Associates#Site Close-out#Site Start-up
#OUS Regulations
Full TimeOn Site0-2 yrs$29 / HOURPosted 6 days ago

Location

Irvine, California

Salary

$29 / HOUR

Quick overview

Supports Clinical Research Associates in managing site start-up, maintenance, and close-out activities for clinical projects. Ensures the accuracy and compliance of study-related documents according to GDP and regulatory standards.

Requirements summary

Requires a Bachelor's degree in a related field. Candidates must possess strong computer skills, professional integrity, and the ability to work independently within a team environment.

bachelor degreeQuality ControlTeamworkAttention To DetailWritten CommunicationVerbal CommunicationMS Office SuiteRegulatory DocumentationClinical Research Support

Job description

Job DetailsJob Location

  • Irvine,
  • CA 92618Position
  • Type:
  • Full
  • TimeEducation
  • Level: 4
  • Year
  • DegreeSalary
  • Range: $29.00 - $29.00
  • HourlyJob
  • Title:
  • Coordinator,
  • Clinical
  • Affairs
  • Supervisor/Manager
  • Title: Director, Clinical Affairs

Job Description

Summary: Supports Clinical Research Associates (CRAs) to manage specific activities related to clinical projects. Job Responsibilities: Participate in site start-up, maintenance, and close-out activities (e.g. tracking site progress, creating regulatory and subject binders, investigate discrepancies, etc.) Provides support to CRAs who are conducting site visits, as needed. Serves as quality control for study-related documents and is accountable for content accuracy to ensure compliance with GDP, US and OUS regulations, and internal company procedures Maintains organization, preparation and ordering of supplies required for clinical studies. Provides support to CRAs for preparing documentation, reports, and presentations. Coordinates study-related meetings, as needed. Minute taker and distributor Other incidental duties QualificationsRequired Education and Experience: Requires a Bachelor’s degree in related field Skills and Abilities Required for This Job: High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently. Good computer skills in usage of MS Office Suite Strict attention to detail Good written and verbal communication skills Must be able to work in a team environment Adhere to all company rules and requirements

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JENAVALVE TECHNOLOGY INC

JENAVALVE TECHNOLOGY INC logo

Hiring organization

JENAVALVE TECHNOLOGY INC

JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System is the first and only device currently approved...

Explore employer profile
IndustryMedical Equipment Manufacturing
TypePrivately Held
Size51-200 employees
HQIrvine, CA
Founded2013
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