IQVIA
ClinicalResearchAssociate(ClientDedicated)
“Clinical Research Associate (Client Dedicated) at IQVIA. Skills: site monitoring, site management, regulatory requirements, GCP, ICH guidelines, protocol knowledge, therapeutic knowledge, computer skills, communication skills, organizational skills, problem-solving skills, time management skills, financial management skills. Perform site monitoring visits (selection, initiation, monitoring and close-out visits). Work with sites to adapt, drive, and track subject recruitment plan”
Industry & Context.
Organizational and problem-solving skills
What They're Looking For.
Must Have
Prior on-site monitoring or equivalent combination of education, training and experience, Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines), Good therapeutic and protocol knowledge as provided in company training, Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable), Written and verbal communication skills including good command of English language, 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 in scientific discipline or health care
What You'll Do.
Perform site monitoring visits (selection
monitoring and close-out visits)
Work with sites to adapt
and track subject recruitment plan
Administer protocol and related study training to assigned sites
Establish regular lines of communication with sites to manage ongoing project expectations and issues
Evaluate the quality and integrity of study site practices
Escalate quality issues as appropriate
Manage the progress of assigned studies
Ensure copies/originals site documents are available for filing in the Trial Master File (TMF)
Verify that the Investigator's Site File (ISF) is maintained
Create and maintain appropriate documentation regarding site management
monitoring visit findings and action plans
Collaborate and liaise with study team members for project execution support
Support development of project subject recruitment plan on a per site basis
Support site financial management according to executed clinical trial agreement and retrieve invoices
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; good command of English language; Establish regular lines of communication with sites
Process & Methodology
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, Effective time and financial management skills
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