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Clin Trial Asst 2 (R1069771) in Kirkland, CA at IQVIA™

Date Posted: 4/8/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Kirkland, CA
  • Experience:
    Not Specified
  • Date Posted:
    4/8/2019
  • Job ID:
    R1069771

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

JOB OVERVIEW
Job Profile Summary    Provide administrative support to clinical projects and update clinical systems and databases under direction of line manager and/or other designated clinical team members. Assists with general administrative functions as required.
Responsibilities
     Essential Functions
•    Assist Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
•    Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.  Assist with periodic review of study files for completeness.
•    Assist CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
•    Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
•    Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
•    May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
•    May perform assigned administrative tasks to support team members with clinical trial execution
•    May Collaborate with Clinical Project Manager (CPM), CRAs/iCRAs and RSU on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.  Assist with periodic review of study files and completeness.
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
Experience
Typically requires a minimum of 2 - 5 years of experience.
 
Knowledge
Requires broad knowledge of operational systems and practices gained through experience and/or education.
 
Education
Education Level    Education Details    Req    Pref     
High School Diploma or equivalent        X         
 
Additional Work Experience
Experience Details    Req    Pref     
3-4 years applicable experience; or equivalent combination of education, training and experience    X         
 
Skills and Abilities
Skill/Ability    Description    Proficiency     
    Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines        
    Broad knowledge of applicable protocol requirements as provided in company training        
    Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint        
    Good written and verbal communication skills including good command of English language        
    Effective time management and organizational skills        
    Ability to establish and maintain effective working relationships with coworkers, managers and clients        
 
Standard ADA Settings
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Standard ADA Selection     Office Environment
 
Physical Demands
Physical Demand    N/A    Rarely    Occasionally    Frequently    Constantly
Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.                   X     
Use hands and fingers to handle and manipulate objects and/or operate equipment.                   X     
 
Travel Requirements
Frequency    Brief Description
    Occasional travel
 
The above information on this description has been designed to indicate the general nature and level of work performed.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job.  While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1069771