Clinical Process Specialist 1

Job Overview
Provide project related assistance for assigned  project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

Essential Functions
•    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.

Qualifications
• 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

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.