Summary

The Clinical Site Liaison (CSL) will serve as a field-based, site-facing resource and extension of Clinical Operations in support of assigned clinical development programs. The CSL will serve as an interface between 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 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 as well as the CRO and investigator sites.

Duties / Expectations of Role

• Working proactively and in close collaboration with client/CRO clinical study teams
• 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:
• Identify operational hurdles/challenges and offer potential strategic solutions; apply mitigations broadly between sites and across 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 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 portfolio
• 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 monitoring oversight activities

Requirements

•  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, 3 years as a Clinical Site Liaison
• Experience in Major Depressive Disorder (MDD) preferred
• Ability to travel 70-80% to locations nationwide is required
• Knowledge of local and FDA regulatory requirements and ICH GCPs

Term & Start

• 12 Month Contract with strong chance of extending
• 100% remote (70-80% travel)
• Full time (40hrs/week); benefits included – health, dental, vision, 401k
• Some overtime may be required