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IQVIA · 22 hours ago

CRA 2, Oncology, Full Service, IQVIA

Kansas City, MO

Full-time

Onsite

Entry Level

$87K/yr - $169K/yr

1+ years exp

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. They are seeking a CRA 2 with oncology monitoring experience to perform site monitoring visits and manage the progress of assigned studies.

AnalyticsHealth CareLife Science

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability

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

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements

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

Collaborate and liaise with study team members for project execution support as appropriate

If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis

If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Qualification

Oncology monitoring experienceClinical Practice (GCP)International Conference on Harmonization (ICH)Site managementRegulatory submissionsBachelor’s DegreeCommunication skillsTeam collaboration

Required

Minimum of 1.5 years of on-site oncology monitoring experience

Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability

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

Collaborate and liaise with study team members for project execution support as appropriate

If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis

If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Bachelor's Degree

1.5 to 2 years of relevant CRA experience including on-site monitoring