As Site Engagement Liaison you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Responsibilities
The Site Engagement Liaison is the main Sponsor point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, this role will utilize and interpret data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. This role is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place. The Site Relationship and Excellence Partner is the “face of Sponsor” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Sponsor’s reputation is that of “Partner of Choice.”
The Site Engagement Liaison proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Sponsor’s pipeline opportunities. This role is accountable for study start up, activation, and execution to the plan for targeted sites. In addition to being the main point of contact, the lead will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Sponsor communications and enhancing overall visibility into and confidence of quality of site-level activities.
Responsible for relationship building and management:
- Usher investigator sites through site activation and study activities from study start up to close out.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Act as the main point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. Follow up and close issue status with investigators to ensure awareness of resolution.
- Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
- Demonstrate leadership within the local clinical development environment with a goal to enhance Sponsor reputation in scientific leadership.
Responsible for proactively providing local intelligence
- Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
- Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
- Review and manage site practices that differ from Sponsor practices and liaise with study teams and study management.
Accountable for study start-up, activation, and execution to plan
For targeted sites:
- Deploy targeted site strategy by qualifying and activating targeted sites, while coordinating Sponsor functions to standardize processes and deliver activation in line with the targeted site strategy.
- Confirm (and educate where needed) that sites are familiar with Sponsor requirements for study start up and facilitate the availability of MSAs when feasible.
- Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
- Conduct SIVs if required.
For all sites:
- Provide enrollment support and ensure progress by responding to start up and recruitment issues investigators, partner with study team to define and support recruitment initiatives at site / country level.
- Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by Sponsor colleagues.
Responsible for CRO and Study Management Interface
- Support local CRO representatives develop positive Investigator relationships throughout the life of the study.
Responsible for process, standards, and oversight
- Responsible for site and monitoring quality, regulatory and GCP compliance.
- Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution.
- Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks. Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control.
- Conduct and report oversight activities, both remote and onsite visits, according to Sponsor requirements and standards.
- Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs. These may be conducted with the assigned CRA or alone depending on the nature of the issue(s).
- Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these.
Protocol Site Oversight
- Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality.
- Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.
Site and Study Management Interface
- Support local Investigator relationship management with the Site Relationship Partner.
- Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.
You are:
- BS/BSc/MS/MSc or equivalent.
- Solid experience as CRA or on the similar position.
- Skills in more than one language are an advantage in this role. English is required.
- Ability to lead, troubleshoot and influence for delivery.
- Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk.
- Effective verbal and written communication skills.
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
