Sr CRA 3 (R1050410) in St Leonards, Australia at IQVIA™

Date Posted: 11/1/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    11/1/2018
  • Job ID:
    R1050410

Job Description

Job Description - Full time or Part time (0.8 FTE) available

Senior Clinical Research Associate required for a single sponsor for 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. The successful candidate will have excellent attention and accuracy with details, strong individual initiative, organizing skills and commitment to quality. They will also have the ability to establish and maintain effective working relationships with coworkers, managers and clients

Responsibilities include but not limited too;

  • 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.

Skills and experience required

  • Bachelor’s degree in a health care or other scientific discipline or educational equitant and 2 years of on-site monitoring experience OR equivalent combination of education, training and experience
  • Good 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

Who you are: You are an experience Pharmaceutical professional looking to develop you career and industry knowledge within a Global CRO.

For further information regarding this or any other vacancies we have at IQVIA please contact the Talent Acquisition Team on 02 9016 8100   



Job ID: R1050410