IQVIA
life sciences and healthcare
ExperiencedCRA
“Experienced CRA at IQVIA. Skills: On-site monitoring, Site management, Clinical research regulatory requirements, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines. Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Perform site monitoring visits (selection, initiation, monitoring and close-”
What You'll Achieve.
Ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements; Enhance predictability of subject recruitment; Manage ongoing project expectations and issues; Evaluate the quality and integrity of study site practices; Ensure the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
Industry & Context.
Organizational and problem-solving skills
Role Location: Belgium, On-site monitoring visits
What They're Looking For.
Must Have
At least 2 years of year of on-site monitoring experience, Excellent command of English and Dutch, At least B1 level of French language, Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, Good therapeutic and protocol knowledge, Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable), Organizational and problem-solving skills, Effective time and financial management skills, Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Nice to Have
Bachelor's Degree Degree in scientific discipline or health care preferred, Equivalent combination of education, training and experience may be accepted in lieu of degree
What You'll Do.
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol
applicable regulations and guidelines
and sponsor requirements
Perform site monitoring visits (selection
monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice
Work with sites to adapt
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
may be accountable for supporting development of project subject recruitment plan on a per site basis
may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement
How You'll Work.
Team & Collaboration
Collaborate and liaise with study team members for project execution support as appropriate; Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Communication Scope
Written and verbal communication skills; Excellent command of English and Dutch; At least B1 level of French language; Establish regular lines of communication with sites
Process & Methodology
Manage the progress of assigned studies, Tracking regulatory submissions and approvals, Recruitment and enrollment tracking, Case report form (CRF) completion and submission tracking, Data query generation and resolution, Effective time management skills
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