09 Feb

Cra Jobs Vacancy at Iqvia

Position
Cra
Company
Iqvia
Location
Opening
09 Feb, 2018 30+ days ago

Iqvia urgently required following position for Cra. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Cra Jobs Vacancy at Iqvia Jobs Details:

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.
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.

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

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.
  • All CRA/SCRAs allocated a dedicated IQVIA line manager.
  • All CRAs will be permanent IQVIA staff.
  • CRAs/SCRA work directly with the sponsor Country Study Management team
  • Ethics/Regulatory submissions are completed centrally by sponsor’s study start up group.
  • Flexi working with 10 – 4 being core office hours

Purpose
Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

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.

Job Requirements

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 a minimum of 3 years of on-site monitoring experience; or equivalent combination of education, training and experience

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 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: 1802708


  • Company: Iqvia
  • Added: 30+ days ago

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