Clinical Site Liaison - Poland (0.75 FTE)

KPS Life is looking to add a CSL to our team in Poland. This is a contract position at roughly 0.75 FTE.

Job Summary

The Clinical Site Liaison (CSL) will serve as a field-based, site-facing resource and extension of Clinical Operations in support of assigned client clinical development programs. The CSL will serve as an interface between client clinical study site personnel, and vendors to ensure quality and timely study execution at the site level. The CSL will be responsible for cultivating and fostering long-term relationships with clinical trial investigators/study site personnel to help position client as a Sponsor of choice. In addition, the CSL will support effective CRO interactions with study sites by developing relationships with key CRO personnel and supporting the development of effective processes and communication between the CRO and client as well as the CRO and investigator sites.

Responsibilities

Working proactively and in close collaboration with client/CRO clinical study teams, the CSL will perform study activities, including but not limited to the following:

• Support patient recruitment and retention initiatives; ensure full leveraging of recruitment and retention tactics by CROs and clinical sites
• Identify and proactively mitigate challenges related to protocol conduct at study sites
• Strategically reviews protocols to ensure operational clarity for investigator sites
• Engage study site personnel (i.e., Principal Investigator, Sub-Investigators, study coordinators, other HCPs, etc.) in discussions to:
• Maintain focus on overall study design, rationale, and eligibility criteria
• Identify operational hurdles/challenges and offer potential strategic solutions; apply mitigations broadly between sites and across studies
• Ensure quality execution of clinical studies
• Participate in SIVs and attend other study visits with or without CRAs
• Help facilitate investigator meetings related to local considerations and relationship building with the site personnel and CRO
• Collaborate and align with study MDs and client cross functional team members on clinical investigator engagement
• Participate in Sponsor, CRO meetings, and cross-functional area operational team meetings (i.e., Study Management Team) while leveraging insight/trends across the client portfolio
• Identify, communicate, and implement lessons learned across sites, regions, and studies
• Help identify needs-based site support, identify issues/trends requiring proactive mitigation and/or escalation, and to provide ad hoc study-related training as needed
• Conduct periodic 1:1 calls with CRO CRA Manager as needed
• Conduct and document client monitoring oversight activities
• Identify, communicate, and implement lessons learned across sites, regions, and studies

Education, Experience, & Skills

• Bachelor’s degree (health sciences or related field preferred)
• Minimum 8+ years clinical research experience in pharmaceutical or biotechnology field, including clinical monitoring and clinical operations study management experience in the biotech/pharmaceutical industry
• Experience in Major Depressive Disorder (MDD) preferred
• Ability to develop robust knowledge of protocol, program goals, disease area, competitive landscape
• Ability to convey scientific and medical information to a diverse audience, and to translate clinical research objectives to strong and clear operational plans
• Ability to travel 70-80% to locations nationwide is required
• Strong vendor management skills
• Experience developing/implementing processes
• Strong written and verbal communication skills; effective collaboration, interpersonal and organizational skills
• Ability to resolve issues independently but escalating when necessary
• Knowledge of local and FDA regulatory requirements and ICH GCPs
• Discerns relevancy of problems; explores options and arrives at solutions that correct situations
• Ability to set appropriate priorities for action, assess the effect of the decision, solution, or action accurately
• Passion, humility, and excitement for doing whatever it takes to drive research forward toward a goal of helping patients with unmet medical needs
• Proven business acumen
• Computer skills: Proficient with Microsoft Office

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