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Form of workJob Description
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments.
We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways.
As a Clinical Research Associate (CRA), you'll play a crucial role within our dynamic team, contributing expertise and dedication to advance cutting-edge healthcare solutions. Your pivotal responsibility involves meticulously overseeing clinical trial sites across the United States, driving the successful execution of trials aimed at enhancing patient care and advancing medical innovation.
Your duties will include co-monitoring, ensuring sponsor oversight of CRO monitoring processes, and fostering strong relationships with study sites, all while upholding strict regulatory compliance. Join us in our commitment to elevate mental health care standards and make a meaningful impact on patients' lives through ground-breaking Clinical Research.
Reports to: Manager, Clinical Operations.
Location: Remote on the East Coast, USA or Hybrid in our NYC office.
Roles and responsibilities(include but are not limited to):
- Conduct comprehensive co-monitoring visits to ensure sponsor oversight of monitoring processes.
- Collaborate with sites to strategize and track subject recruitment plans aligned with project needs
- Deliver protocol and study-related training, maintain consistent communication channels with sites
- Involved in kick-off meetings, ensuring all necessary stakeholders attend and fostering an environment conducive to clear communication, goal alignment, and effective initiation of clinical trials
- Assess and maintain quality and integrity of study site practices, escalating concerns as needed
- Track study progress: regulatory submissions, approvals, recruitment, CRF completion, data query resolution
- Manage Trial Master File (TMF), ensure document availability and ISF compliance with regulations
- Document site management, visit outcomes, and action plans via detailed reports and follow-up correspondence
- Collaborate with study team members, providing essential project execution support
- Contribute to developing project-specific subject recruitment plans
- Potentially manage site financials as outlined in the clinical trial agreement, including invoice retrieval per local requirements
- Clinical research experience including extensive monitoring experience for phase II and III clinical trials
- Experience in Pharma/Biotech, CRO is essential
- Willing to travel regularly and countrywide
- An inquiring mind and great enthusiasm to work in an exciting and fast-moving environment
- Knowledge of ICH and GCP guideline
- Ability to operate independently and in cross-functional teams
- Aligned to our company mission and values of Compassionate, Bold, Rigorous and Inclusive
For an overview of our benefits package and compensation information, please visit "Working at COMPASS".
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work and any role at COMPASS, regardless of the location, is eligible for additional discretionary bonuses and equity.
UK applicants
We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.
US applicants
COMPASS Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.
