CRA 1/2 (R1111247) in Paris, FR at IQVIA™

Date Posted: 2/3/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Paris, FR
  • Experience:
    Not Specified
  • Date Posted:
    2/3/2020
  • Job ID:
    R1111247

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.

CRA 1/2 - Site Management Department - based in La Defense

Monitors during clinical research studies to ensure trials are being conducted in accordance with widely accepted clinical practices. Conducts on-site and remote monitoring; develops tools, procedures and processes to ensure quality monitoring.

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


 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.

• Build awareness of 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.

Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.
Bachelor's Degree Health care or other scientific discipline or educational equivalent
1 year of on-site monitoring experience X Or Equivalent combination of education, training and experience

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.



Job ID: R1111247