IQVIA
ExperiencedClinicalResearchAssociateSponsor-dedicated
Neural analysis suggests this role is
optimal for Mid candidates.
“Experienced Clinical Research Associate Sponsor-dedicated at IQVIA. Skills: Site monitoring, Site management, Protocol adherence, Regulatory compliance. Perform monitoring visits. Perform site selection visits”
Industry & Context.
Problem-solving skills
What They're Looking For.
Must Have
2 years of on-site monitoring experience, Good clinical practice knowledge, ICH guidelines knowledge, Proficiency in Microsoft Word, Proficiency in Microsoft Excel, Proficiency in Microsoft PowerPoint, Proficiency in laptop computer use, Proficiency in iPhone use, Proficiency in iPad use, Written communication skills, Verbal communication skills, Command of Greek language, Command of English language, Organizational skills, Problem-solving skills, Effective time management skills, Effective financial management skills, Ability to establish working relationships
Nice to Have
Degree in scientific discipline preferred, Degree in health care preferred
What You'll Do.
Perform monitoring visits
Perform site selection visits
Perform site initiation visits
Perform site monitoring visits
Perform site close-out visits
Adapt subject recruitment plan
Drive subject recruitment plan
Track subject recruitment plan
Administer protocol training
Administer study training
Establish communication lines with sites
Manage project expectations
Manage project issues
Evaluate site practice quality
Evaluate site practice integrity
Escalate quality issues
Manage study progress
Track regulatory submissions
Track regulatory approvals
Track data query generation
Track data query resolution
Support start-up phase
Ensure site documents are available
File documents in TMF
Verify ISF maintenance
Create site management documentation
Create monitoring visit findings documentation
Create action plan documentation
Submit regular visit reports
Generate follow-up letters
Generate required study documentation
Collaborate with study team members
Liaise with study team members
Support project execution
Support development of recruitment plan
Support site financial management
How You'll Work.
Team & Collaboration
Study team members
Communication Scope
Written communication; Verbal communication; Greek language; English language
Full Job Description
**Job Overview** 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. **Essential Functions** • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. • 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. **Qualifica
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