Clinical Research Associate - Single Sponsor Dedicated (R1054789) in Reading, UK at IQVIA™

Date Posted: 10/3/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
    10/3/2019
  • Job ID:
    R1054789

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.

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.

A career with IQVIA connects you to great opportunity to achieve professional success and impact healthcare around the world.

Role

We are currently looking for the experienced CRAs to join our single sponsor dedicated model.

Key Points
• Single sponsor, client facing role in IQVIA single sponsor department
• True partnership between IQVIA and the sponsor with a good culture
• CRA/SCRA would be allocated to 1-2 protocols
• Approximately 10 sites allocated to each CRA/SCRA (10 in total, not per protocol)
• The sponsor model has reduced travel (approximately 30% or less), this is due to using ‘Fit for Purpose monitoring’ which incorporates remote monitoring.Therefore there is less need for on-site visits.


Responsibilities
• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• 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 to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
• 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 to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.

Required Knowledge, skills and abilities
• In depth knowledge and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• In depth therapeutic and protocol knowledge as provided in company training
• Strong written and verbal communication skills including good command of English language
• Excellent organizational and problem-solving skills
• Effective time management skills
• Ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients


Minimum Required Education & Experience
Bachelor's degree in a health care or other scientific discipline or educational equivalent and on-site monitoring experience; or equivalent combination of education, training and experience

What We Offer / USPs

  • We invest in keeping our teams stable so workload is consistent
  • We offer genuine career development opportunities for those who want to grow as part of the organisation
  • The chance to work on cutting edge medicines right at the forefront of new medicines development
  • IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. Next generation clinical development!
  • As a CRA you will receive an iPad and use of key developments such as site visit app’s, site visit report app’s that allow CRA’s to do their day job more efficiently.

Awards

  • FORTUNE Magazine's World's Most Admired Companies list for the third year in a row.
  • Recognised by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO).
  • Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year. A site-nominated award recognising contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity.
  • IQVIA named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.

 
IQVIA is an equal opportunity employer. We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other 'protected status.'
 
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™.

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: R1054789