CRA 2, Oncology, IQVIA

IQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. The CRA 2, Oncology, conducts on-site monitoring visits, oversees regulatory and study documentation, manages site progress and recruitment, and supports clinical trial execution in accordance with GCP, ICH, and regulatory requirements.

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

Preferred

• (Degree in scientific discipline or health care preferred)
• Scientific Degree
• Healthcare Degree

Benefits

• Incentive plans, bonuses, and/or other forms of compensation may be offered
• A range of health and welfare and/or other benefits

Company

• Clinical research, commercial insights, and healthcare intelligence for life sciences.
• Durham, North Carolina, USA
• https://www.iqvia.com/
• Founded in 1982
• 10001+ employees

Qualifications

• IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience:
• Education: Bachelor's Degree
• Experience: 1.5 to 2 years of relevant CRA experience including on-site monitoring
• (Degree in scientific discipline or health care preferred)
• Experience: 1.5 to 2 years of relevant CRA experience including on-site monitoring.

Required skills

• Case Report Form (CRF) Management, Clinical Practice (GCP), Clinical Trial Regulatory Compliance, Clinical Trial Site Monitoring, International Conference on Harmonization (ICH) Guidelines, Oncology Clinical Research

Preferred skills

• (Degree in scientific discipline or health care preferred)

Experience

• 1-2 years