**Real World Evidence Solutions CRA** - (1807342) in Reading, UK at IQVIA™

Date Posted: 5/10/2018

Job Snapshot

Job Description


IQVIA- Real World Evidence Solutions has exciting permanent career opportunities on offer for CRAs.

Within IQVIA, the Real World Evidence business unit employs over 1,000 dedicated staff to design, implement and manage real-world and post-marketing studies. As healthcare stakeholders increasingly need evidence to support regulatory, reimbursement and prescribing decisions, the IQVIA RWE team offers a comprehensive evidence approach to meet our customer’s unique needs for demonstrating safety, effectiveness and quality.

  • May perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.
  • Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
  • Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
  • 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), Site Management Lead (SML) and/or line manager.
  • Execute assigned work efficiently and adhere to project timelines and financial goals
  • Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, 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, essential document collection and filing and other required study documentation.
  • May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.


Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Strong written and verbal communication skills in applicable languages, and business level command of English
  • Good organizational, interpersonal and problem-solving skills
  • Strong attention to detail
  • Working time management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor’s Degree preferably in life science, and proven monitoring experience.

WHAT WE CAN OFFER YOU:

At IQVIA you have the opportunity to make a lasting impact on our customers, the industry, patient health around the world, and your career.

We are committed to rewarding your contributions with a combination of competitive salaries, comprehensive benefits, and an award winning culture. 



Job ID: 1807342