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Sr CRA 1 (R1076842) in Overland Park, KS at IQVIA™

Date Posted: 5/26/2019

Job Snapshot

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

JOB OVERVIEW
 Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Senior Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

Responsibilities
     Essential Functions
•    Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
•    If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
•    Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
•    Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
•    Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.  Escalate quality issues  as appropriate
•    Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
•    Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
•    Act as a mentor for clinical staff including conducting co-monitoring and training visits.
•    May provide assistance with design of study tools, documents and processes.
•    Convey features and opportunities of study to site.
•    Collaborate and liaise with study team members for project execution support as appropriate.
 
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 2 - 3 years of prior relevant experience.
 
Knowledge
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
 
Education
Education Level    Education Details    Req    Pref     
Bachelor's Degree    Health care or other scientific discipline or educational equivalent     X         
 
Additional Work Experience
Experience Details    Req    Pref     
2 years of on-site monitoring experience    X         Or
Equivalent combination of education, training and experience”    X         
 
Skills and Abilities
Skill/Ability    Description    Proficiency     
    Strong knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines        
    Strong therapeutic and protocol knowledge as provided in company training        
    Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer        
    Strong written and verbal communication skills including good command of English language        
    Strong organizational and problem-solving skills        
    Effective time management skills        
    Ability to manage competing priorities        
    Good mentoring and training 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
Frequent    
 
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

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

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

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1076842