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IQVIA

Runs drug trials and sells health data to pharma

CRA 2 – Oncology

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeIn-person

About the Job

Requirements

  • A bachelor's degree is required; a degree in a scientific discipline or health care is preferred.
  • At least 1.5 years of on-site oncology monitoring experience is required.
  • Between 1.5 and 2 years of relevant CRA experience, including on-site monitoring, is required.
  • Knowledge of Good Clinical Practice and International Conference on Harmonization guidelines is required.

Responsibilities

  • Perform site selection, initiation, monitoring, and close-out visits in accordance with the contracted scope of work and regulatory requirements, including Good Clinical Practice and International Conference on Harmonization guidelines.
  • Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
  • Administer protocol and related study training to assigned sites, and establish regular communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study-site practices related to protocol conduct and regulatory adherence, and escalate quality issues as appropriate.
  • Manage assigned study progress by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data-query generation and resolution; may support the start-up phase.
  • Ensure required site documents are available for filing in the Trial Master File and verify that the Investigator's Site File is maintained in accordance with Good Clinical Practice and local regulatory requirements.
  • Create and maintain site-management documentation, monitoring-visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and preparing other required study documentation.
  • Collaborate and liaise with study-team members to support project execution, as appropriate.
  • If applicable, support development of a project subject-recruitment plan on a per-site basis.
  • If applicable, manage site finances according to the executed clinical trial agreement and retrieve invoices according to local requirements.

Desired Qualifications

  • A degree in a scientific discipline or health care.

About the Company

IQVIA

Runs drug trials and sells health data to pharma

IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.

Company size
10,001+
Company stage
IPO
Headquarters
Durham, NC
Founded
1998

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