IQVIA Hiring for Clinical Process Specialist 1 Job at Thāne Full Time

• Manage and oversee a caseload of visit report reviews for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA applicable SOPs, and GCP guidelines independently.
• Lead a comprehensive review of the visit reports in order to ensure all site issues are adequately documented, reported and followed up to resolution, as well as, assuring a high quality of SVRs.
• Serve as the lead SRS on assigned projects when more than one SRS is assigned.
• Develop, in collaboration with CLs at project start-up and throughout the study, site visit report annotations, guidelines, and assure efficient completion of visit reports by the CRAs.
• Provide training for CRAs of study site visit report annotations and reports writing.
• Manage and oversee the project team compliance to SOPs for submission and approval of the visit report through direct communication with the CRA and/or if necessary with Site Resource Manager (SRM).
• Document and escalate issues noted in the site visit report which could impact subject safety, regulatory compliance and/or data integrity to the CLs and CRA SRM, as necessary.
• Review the visit reports to ensure documentation and implementation of e.g. audit or inspections, findings or focused site visit observations requiring corrective and /or preventative action plans.
• Attend regular teleconferences with CLs to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs in a given project. Assist the CLs with review of the trends emerging from the Issue Escalation Log.
• Work with the project team members to decrease the level of corrections/additions needed on reports, provide continuous support to CRAs with regard to reports’ writing requirements, providing ongoing mentoring, coaching and better understanding of the SVR annotations.
• Work with CRAs and study teams to support Open Action Items Management.
• Provide additional team SRS support through other activities such as quality checks, data trending, providing back up support, mentoring and coaching of junior SRSs.

• Bachelor’s Degree Bachelor’s degree in a healthcare or other scientific discipline or educational equivalent

Requirements

• 3 years of Clinical Research experience, including a minimum of 2 years on-site monitoring experience.
• Equivalent combination of education, training and experience.
• “Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.

5 plus years overall experience