JOB OBJECTIVE: The Clinical Operations Associate Project Manager (COAPM) at Usona Institute is a key member of the Clinical Operations team. The COAPM is responsible for the management and coordination of all psychedelic clinical trial activities. This role requires a highly motivated individual who has a blend of experience and expertise. The ideal candidate should have experience in clinical trial management and demonstrate a drive and interest in clinical trials with the unique demands of psychedelic research.
CORE DUTIES:
1. Oversee the execution and progress of clinical trials, ensuring compliance with study protocols, regulatory requirements, and ethical standards.
2. Collaborates with Clinical Operations Manager/Leads in the management and execution of Phase 2/3 Clinical studies; may also lead for Phase 1 clinical studies.
3. Coordinate and manage project timelines, resources, and budget ensuring compliance with SOPs and regulatory requirements.
4. Contribute to the development and review of clinical trial documents, including protocols, study plans, informed consent forms, and case report forms.
5. Liaise with external stakeholders, CROs (Contract Research Organizations), and clinical sites.
6. Monitor and report on trial progress, identifying and mitigating risks.
7. Creation and maintenance of study metrics and reports to provide regular updates to the Study Teams.
8. Coordination of study and project-related meetings.
9. May act as a central contact for the study team for designated project communications, correspondence, and associated documentation.
10. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
11. Embracing and being open to incorporating Emotional & Social Intelligence (ESI) core principles in daily work.
12. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
KEY QUALIFICATIONS:
1. Bachelors degree in a life sciences, healthcare, or related field.
2. Minimum of 3 years of clinical research experience, preferably within the pharmaceutical industry or CROs.
3. At least 1 year of experience in Clinical Project or Clinical Trial Management.
4. Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment.
PREFERRED QUALIFICATIONS:
1. Experience in psychiatric or neurological clinical trials, particularly with psychedelic compounds.
2. Certification in Project Management (e.g., PMP).
3. Experience in Phase 2 or 3 clinical trials.
PHYSICAL DEMANDS:
1. Ability to use computer equipment.
2. Occasional travel may be required.

At Usona, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.