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Clinical Research Associate, IQVIA Biotech

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IQVIA

3mo ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • New York

AI generated summary

  • You need a bachelor's in life sciences, 1 year on-site monitoring experience, strong GCP/ICH knowledge, and willingness to travel as needed for the project.
  • You will conduct site visits, collaborate on recruitment strategies, train staff, monitor compliance, track study progress, manage documentation, and support cross-functional teams.

Requirements

  • Bachelor’s degree in life sciences or health-related field (or equivalent experience).
  • Requires at least 1 year of on-site monitoring experience.
  • Strong understanding of GCP, ICH guidelines, and regulatory requirements.
  • Ability to travel as required by the project.

Responsibilities

  • Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
  • Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
  • Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
  • Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
  • Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
  • Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
  • Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
  • Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
  • Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

FAQs

What is the minimum experience required for the Clinical Research Associate (CRA) position?

The minimum experience required is 1 year of on-site monitoring. However, we will also consider CRA 1 candidates with a minimum of 6 months of on-site monitoring experience.

Is monitoring experience in a specific therapeutic area required?

Yes, candidates must have experience monitoring in oncology solid tumors.

What qualifications are necessary for this position?

A Bachelor's degree in a life sciences or health-related field (or equivalent experience) is required, along with at least 1 year of on-site monitoring experience.

What travel requirements does this position entail?

The position requires the ability to travel as needed based on project requirements.

What types of site visits will the CRA be responsible for?

The CRA will conduct all types of site visits, including selection, initiation, monitoring, and close-out visits.

What are the key responsibilities of the Clinical Research Associate?

Key responsibilities include monitoring compliance with study protocols, collaborating with site staff on recruitment strategies, providing training, assessing site performance, tracking regulatory submissions, and documenting site management activities.

Does IQVIA Biotech provide training for new employees?

Yes, the CRA will deliver protocol and study-specific training to site personnel and maintain communication to manage expectations.

What guidelines and regulations must the CRA adhere to?

The CRA must adhere to Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and regulatory requirements.

What is the potential base pay range for the CRA role?

The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00, with actual pay varying based on qualifications and other factors.

Are there benefits included in this position?

Yes, in addition to base pay, there may be incentive plans, bonuses, and other forms of compensation, along with health and welfare benefits.

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IQVIA

Accelerate innovation for a healthier world.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures.

Benefits

  • Medical, dental and vision coverage

  • Employee Assistance Programs

  • Mental health support

  • Flexible work environment

  • Time off for leisure, personal time and corporate holidays

  • Parental leave for birth or adoption

  • Paid leave for other life matters (i.e., illness, bereavement, jury duty, military service, etc.)

  • Retirement and savings plans

  • Commuter benefits

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