CTI

What You'll Do Review scope of project and resourcing related to Clinical Monitoring with Clinical Project Management Plan, schedule, and implement the clinical monitoring aspects of projects Define and implement project-specific functional standards, goals, and expectations with Clinical Monitoring

What You'll Do: Oversee and guide eTMF processes and specific timelines assessments for each trial; monitor against trial progress and ensure trial activity is in compliance with relevant processes; suggest and implement alternative solutions for issues identified and take corrective action where ne

About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of develo

About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of develo

Job Purpose The Medical Director will be responsible for growing and leading a therapeutic portfolio through their medical and clinical development expertise and by providing medical and safety monitoring of awarded clinical trials. The Medical Director will be responsible for playing a leadership r

What You'll Do: Regulatory Submission Management Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS. Handle regulatory submissions for medical devices, GMOs, and local country requirements in countries where CTIS is not mandated, including ethics com

What You'll Do Support Clinical Project Manager / Director in completing clinical project management activities; support activities throughout all phases of a clinical project, including any SOP-required deliverable as appropriate Update Clinical Project Manager / Director on progress, outstanding i

What You'll Do Work with Human Resources to fulfill all hiring need and take lead role in their training and development Manage workloads and project assignments of RAs, Senior RAs, Lead RAs and potentially Assistant Managers within the group Demonstrate ability to effectively lead liaison meetings

** Please submit your application in English ** What You'll Do: Initiate site contact and follow-up as necessary to turn study confidentiality agreements (CDA) and study clinical trial agreement (CTA) drafts Administer contract language to ensure it remains within approved sponsor guidelines and wor

What You'll Do Maintain a working knowledge of different types of collection tubes and kits, e.g., blood collection tubes, aliquots Maintain kitting department and create an organized workflow to ensure accurate kit building Assemble kits and all required documentation; participate in the quality co

About the job This position is responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisati

About the job: Responsible for assisting with the analysis and management of essential trial documentation for multiple regulated projects; Successfully and efficiently analyze and quality control (QC) individual trial/project specific essential regulatory documents What You'll Do: Organize, manage,

About the job: Responsible for assisting with the analysis and management of essential trial documentation for multiple regulated projects and developing skills to successfully and efficiently analyze and quality control (QC) individual trial/project specific essential regulatory documents. What You

Job Summary: The Associate Director provides leadership role in facilitating the management of the multiple Phase I-IV clinical research trials across all geographic and functional areas; Responsible for ensuring that direct reports and assigned clinical operation's team members deliver their projec

What You'll Do: Assist with the development and modification of department SOPs and work instructions Assist with training new statistical programmer employees; mentor and assist junior level programmers Assist with the development of study bids and changes in scope for Statistical Programming tasks

About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of develo

What you'll do: Serve as the main CTI contact for assigned study sites Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in the Monitoring Plan while adhering to all

What You'll Do: Serve as main CTI contact for assigned study sites Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applica

This position will be office based at either our headquarters located in Covington, KY or our office in Raleigh, NC. Job Summary: Provides strategic and operational leadership for the global Regulatory Affairs Study Start-Up (RASSU) function, with accountability for organizational performance, deliv

What You'll Do: As the lead Biostatistician on the studies assigned, perform the following tasks: Act as primary statistical contact for internal and external project team members. Communicate and work with Biostatistics management to maintain the project budget and timelines. Review case report for