Sr. CRA/CRA 2, Oncology, Full Service - IQVIA
Sr. CRA/CRA 2, Oncology, Full Service - IQVIA
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Job Description
IQVIA is seeking a Sr. CRA 1 or CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience:
Essential Functions
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 Investigators 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.
Education: Bachelors Degree (Degree in scientific discipline or health care preferred)
Experience: 1.5 to 2 years of relevant experience including on-site monitoring.
#CRAFSAJD
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $69800.00 - $226800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and/or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.
Required Experience:
Senior IC
Employment Type
Full-Time
