Site Engagement Clinican

Description

• Site Engagement Clinician Serves as a clinical site liaison and point of contact to develop and maintain high productivity amongst a group of investigative sites.
• Requires strong understanding of the assigned protocols and study population in order to respond to questions pertaining to the study inclusion/exclusion criteria, dosing strategy and other study related questions.
• Primary purpose of this role is to ensure investigative site has understanding of the protocol requirements and to partner with the site to identify successful screening methods that will translate to the productive randomization of appropriate study subjects, build and maintain ongoing enrollment pattern and risk mitigation for enrollment deficiencies.
• Creating site motivation for optimal enrollment performance is a key responsibility.

• Serves as a clinical site liaison and point of contact to develop and maintain high productivity amongst a group of investigative sites.
• Responsible for building and maintaining scientific relationships with an assigned group of investigative sites.
• Development of an ongoing dialogue with the investigative site either through in person visits, virtual meetings, teleconferences and e-mail as appropriate for the situation, site productivity and quality.
• Requires strong understanding of the assigned protocols in order to respond to questions pertaining to the study inclusion/exclusion criteria, dosing strategy, and other study related questions. In this regard, high-touch site protocol training should occur regularly with assigned sites and coaching sessions in the areas of subject recruitment and retention.
• Given the high frequency of such interactions, telephone calls and Webex virtual meetings will be the most common form of communication.
• Work with the investigative site to identify successful screening methods that will translate to the productive randomization of appropriate study subjects and build and maintain ongoing enrollment pattern in order to achieve the targeted randomization per site.
• Discuss the recruitment expectations with the investigative site in a direct, non-confrontational manner, focusing on productive screening efforts.
• Explore and identify reasons for screening failures, encouraging and coaching on bona fide screening failure rather than less productive screening efforts.
• Identify factors that may be inhibiting productive enrollment at the site.
• This may require a face to face interaction to clearly identify barriers and factors with negative impact.
• Liaise between site, CRO, Lead Clinician for the study, and others as appropriate to resolve recruitment barriers.
• Identify and drive solutions that will resolve conflict.
• Encourage commitment to protocol compliance, particularly in study drug administration compliance coaching and retention of subject in study for duration of trial.
• Identify investigators that require supportive coaching and encouragement.
• Collaborate with study team and site Clinical Research Associate in order to provide productive information that will facilitate and support site monitoring.
• Provide study team support during study-up phase by actively participating in site identification and feasibility assessments

• GCP knowledge is required
• Experience is minimum 5 years