Travel to sites involved****
PURPOSE:
The Clinical Trial Liaison (CTL) serves as a key bridge between investigative sites, sponsors, and contract research organizations (CROs) in psychedelic clinical trials. In addition to supporting trial operations, this individual is responsible for quality oversight of Clinical Research Associates (CRAs), ensuring regulatory compliance, data integrity, and adherence to Good Clinical Practice (GCP) standards.
The CTL acts as the primary point of contact for investigative sites throughout the study lifecycle. This role is accountable for supporting site start-up through activation, building and maintaining strong site relationships, supporting site-level operational success, overseeing recruitment efforts, and safeguarding trial quality and patient safety at the site level.
The CTL contributes to country and site selection activities by collaborating with key stakeholders and providing regional insights to feasibility assessments, outreach surveys, investigator strategies, and future pipeline opportunities. As the “face of the sponsor,” the CTL ensures sites receive appropriate support and engagement, issues are promptly resolved, and the sponsor’s reputation is upheld throughout the trial.
Additionally, the CTL coordinates with other roles that interface with study sites (e.g., Study Monitor, Contracts Lead, Site Activation Partner, Clinician) to streamline communication and enhance oversight of site-level activities.
The CTL is responsible for site oversight by utilizing analytic tools and country intelligence to identify risks to quality and compliance, and by developing and implementing mitigation plans as needed.
This individual will collaborate with internal and external stakeholders and multidisciplinary teams to advance clinical programs. Flexibility, adaptability, and creativity are essential, particularly in a fast-growing and evolving environment.
A strong commitment to addressing unmet needs in mental health, and a genuine passion for supporting patients through psychedelic-based therapies, is essential.
Site Start-Up & Activation
- Responsible for site start-up and activation activities.
- Support site qualification and activation strategies for assigned sites.
- Contribute to country and site selection by reviewing potential site lists and feasibility inputs.
- Collaborate with stakeholders to provide regional insights into outreach surveys, protocol feasibility, standard of care, and local practices.
- Maintain thorough knowledge of assigned study protocols.
- Oversee CRO execution of site-level start-up activities, including activation checklists, informed consent document finalization, and site initiation activities.
- Ensure timely completion of post-SIV activities to support site readiness for first patient visit.
- Partner with monitors to ensure monitoring readiness prior to site activation.
- Build and maintain strong relationships with investigator sites.
- Coordinate resolution of escalated site-level issues (e.g., vendor concerns, payment delays, contract challenges).
- Support strategies for investigational product and ancillary supply management throughout the study.
- Develop and oversee site-level recruitment plans aligned with global and regional targets.
- Provide enrollment support by monitoring progress and addressing recruitment challenges.
- Maintain regular communication with sites to gather status updates and drive progress on study goals.
Study Conduct & Close-Out
- Serve as the operational point of contact for site-level questions, escalating issues as needed.
- Review Site Monitoring Reports.
- Maintain consistent communication with sites to gather updates, performance metrics, and general study feedback.
- Oversee site deliverables related to study milestones (e.g., data cleaning, interim analyses, database locks, investigator signatures).
- Execute study oversight plans and proactively mitigate anticipated risks.
- Ensure quality and consistency in monitoring practices.
- Drive monitoring efficiencies and contribute to best practices across studies.
- Support local clinical development efforts to strengthen scientific reputation.
- Act as a subject matter resource for systems and processes as assigned.
- Identify opportunities to improve site satisfaction and enhance site-sponsor relationships.
- Maintain open communication with the Study Operations Manager.
- Support monitors in developing strong investigator relationships and escalate training or compliance concerns.
- Provide input into site recommendations based on knowledge of regional performance, processes, and metrics.
Clinical Trial Liaison Responsibilities
- Serve as the primary contact between study sites, sponsors, and CROs.
- Support investigator engagement and relationship management.
- Provide guidance on regulatory expectations and overall trial conduct.
- Facilitate protocol adherence and support training on psychedelic-specific study requirements.
CRA Quality Oversight Responsibilities
- Oversee and assess CRA performance related to monitoring, compliance, and protocol adherence.
- Conduct audits, co-monitoring visits, and evaluations to ensure data quality and regulatory compliance.
- Promote consistent monitoring approaches across programs.
- Review Clinical Monitoring Reports.
Education and Experience
- Bachelor’s degree required.
- Minimum 5 years of experience in the biotechnology/pharmaceutical industry in clinical monitoring, project support, or study oversight.
- Demonstrated experience in site management, including prior experience as a site monitor.
- Experience supporting start-up through site activation.
- Experience in study conduct and close-out activities.
- Strong understanding of applicable regulatory and quality requirements.
- Knowledge of GCP/ICH Guidelines and global regulatory expectations.
- Proficiency with digital tools and willingness to adopt new technologies.
- Strong communication, presentation, and interpersonal skills.
- Ability to travel up to 75%.
- Demonstrated relationship-building and networking skills.
- Proven ability to manage cross-functional interactions.
- Effective communication with internal and external stakeholders.
- Adaptability to changing processes and technologies.
- Knowledge of country-specific GCP requirements.
- Ability to remove barriers and support implementation of new processes.
- Ability to build strong relationships with investigator site personnel and stakeholders.
- Strong initiative, attention to detail, and ability to work effectively in a fast-paced environment.
- Commitment to working within an agile, collaborative, team-based structure.