Sr CRA 1 (R1115573) in Lima, Peru at IQVIA™

Date Posted: 2/5/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Lima, Peru
  • Experience:
    Not Specified
  • Date Posted:
    2/5/2020
  • Job ID:
    R1115573

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 Profile Summary    

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  
Bachelor's Degree Required      
 
Additional Work Experience 

  • 2 years of on-site monitoring experience   
  • Equivalent combination of education, training and experience         

 
Skills and Abilities

  •     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       

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: R1115573