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Clinical Trial Liaison - MidWest

Company: The Medical Affairs Company
Location: Bloomington
Posted on: February 9, 2020

Job Description:

The Clinical Trial Liaison (CTL) supports clinical study execution as the regional field-based representative for the Company supporting clinical development programs. The CTL interacts with investigator sites and other cross functional study team members related to clinical trial execution. The CTL provides specific insights to support study feasibility, site identification and selection, and patient recruitment and retention initiatives. In collaboration with the study team, the CTL both identifies and helps facilitate resolution of investigator site issues. The CTL will provide operational insight into site feasibility and selection and overall patient recruitment strategy The CTL will participate in Clinical Study Team Meetings and Quality Review Meetings where necessary providing input to study teams on operational issues based on site visits and contacts Designs POC-enabling human studies, First-In-Human (FIH) studies, POC (clinical and/or pharmacologic) studies as per clinical strategy Analyzes the benefits and risk aspects of an assigned therapeutic candidate Reviews and finalizes the medical and scientific portions of clinical study concepts (CSCs) and clinical study protocols (CSPs) and amendments Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions Attend and present at investigator meetings, monitor workshops Participate in site visits with investigators site staff and CRO representatives in support of clinical trial execution and report back to study teams eg. feasibility, start up activities, enrollment or escalated site issues Provides sponsor regional operational support and acts as point of escalation for investigator sites Participate in Regulatory GCP inspections and/or audits at investigator sites as sponsor representative Qualifications: MSN, MSc, BS Clinical trial management-- or Sr. CRA experience required Minimum 8 years of clinical research pharmaceutical industry experience whether directly or through a CRO Extensive medical and scientific knowledge and clinical development understanding Computer skills including Excel, Word, and PowerPoint A willingness to travel frequently within assigned geographical territory, including overnight travel.

Keywords: The Medical Affairs Company, Bloomington , Clinical Trial Liaison - MidWest, Healthcare , Bloomington, Illinois

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