CRA Trainee (f/m) - office based in Amsterdam (R1055619) in Amsterdam, NL at IQVIA™

Date Posted: 10/7/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Amsterdam, NL
  • Experience:
    Not Specified
  • Date Posted:
    10/7/2019
  • Job ID:
    R1055619

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.

PURPOSE

Engage in company training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Transition to an independent CRA role after the training period.

RESPONSIBILITIES

  • Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
  • Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Research Specialist (CRS) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as Data Management and Pharmacovigilance.
  • Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
  • Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
  • Under close supervision, 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), CRS and/or line manager.
  • Under close supervision, 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.
  • Under close supervision, 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.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Any clinical research related experience/practice is an advantage 
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
  • Good written and verbal communication skills including good command of English and Dutch languages
  • Basic organizational and problem-solving skills
  • Working time management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

 MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Degree or currently enrolled in bachelor's degree program in health care or other related discipline; or equivalent combination of education, training and experience. PhD / post-doc is preferred.

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: R1055619