Join a Pioneering Clinical Research Team—Apply by May 12!
Job Title: Clinical Research Associate
Job Type: Full-Time
Location: Remote, Some travel may be required (Up to %20)
Department: Clinical Research
Reports To: Clinical Research Manager & CEO
Start Date: Spring 2025
To ensure your application is reviewed, please email your resume and a 1-page cover letter to Spencer@therapsil.ca and CC Kamaya@therapsil.ca by May 12.
About TheraPsil
Over the past five years, TheraPsil has established itself as the leading voice in Canada’s psychedelic sector. We have proudly facilitated the first legal access to psychedelics for Canadians, spearheaded a Charter challenge to shape medical psychedelic regulations, and trained over 750 healthcare professionals in the practice of psychedelic-assisted psychotherapy. Looking to the future, we are excited to initiate our first clinical trial aimed at exploring and innovating the use of psilocybin-assisted psychotherapy in group settings. Our mission is to promote safe, legal, and accessible psychedelic healthcare by advancing pioneering research and comprehensive training in psychedelic therapeutics.
TheraPsil is developing the infrastructure to conduct a psilocybin clinical trial to understand its effects on mental health and wellness. This research will help inform clinical care and the development of regulations for psychedelic care in Canada.
We are looking for individuals to help build our vision of open and accessible psilocybin clinical research in communities nationwide.
Learn more about us here: https://therapsil.ca/about/
About the Study
The study is an open-label, oral dose, single-period cohort study to assess the efficacy of Psilocybin in assisted group therapy for improving wellness.
Job Summary
As an experienced Clinical Research Associate (CRA), you will be instrumental in the development of CRO infrastructure and provision of site oversight. The CRA facilitates communication between sites and Sponsor and assists in project management. Your role will involve managing study activities across sites, ensuring compliance with regulatory standards, and facilitating effective communication among research staff, participants, and stakeholders.
Key Responsibilities
- Act as a liaison between sites and the Clinical Research Manager to ensure projects meet performance indicators and remain within timelines\
- Oversee the operational aspects of the CRO and overall project management. This includes:
- Coordinate site contracting, budgeting, insurance, and payment processes by supervising local support roles
- Assist sites in meeting recruitment targets and ensure all recruitment efforts are within regulatory and ethical guidelines
- Organize and manage the schedules of research staff required for site visits
- Use strong attention to detail to review source data for Quality Assurance purposes within our electronic data capture (EDC) and clinical trial management (CTM) software
- Assist the Clinical Research Manager with monitoring activities including audit inspection readiness, data verification and cleaning, and routine monitoring
- Monitor site progress and ensure participants and research personnel comprehend the study protocol
- Monitor the ongoing clinical status of participants, ensuring adverse events, protocol deviations, and areas of improvement are identified and followed through to resolution
- Implement regulatory agency inspection readiness activities
- Provide updates regarding enrollment, attrition, logistical inefficiencies, site needs, and other items as necessary to stakeholders
- Proactively identify, resolve/mitigate, and escalate risks and/or issues to the Qualified Investigator as necessary
- Ensure project team members are trained (e.g., ICH-GCP, TCPS2, Division 5, SOP, indication, protocol, study-specific procedures/requirements, etc.) to perform their assignments
- Develop, review, and revise project documents (e.g., monitoring plan, CRF completion guidelines, study-specific operating manual, study-specific forms, etc.)
- Initiate corrective/preventive measures such as updating study guidance documents, performing re-training, and conducting co-monitoring
Qualifications
- 2+ years of progressive clinical research experience including monitoring, regulatory submissions and audits and site management.
- Experience with phase 2/3 trials.
- Ability to work in a fast-paced small CRO environment and manage multiple projects.
- At minimum, a BSc in a science related field.
- Ability to work effectively with minimal supervision.
Preferred Qualifications:
- Sponsor-dedicated experience
- Experience in managing psychotherapy or psychotropic drug trials.
- Certification as a Clinical Research Coordinator (e.g., CCRC, CCRP).
- Experience coordinating multisite and/or multi-region clinical studies (including international studies)
Additional Information
Why TheraPsil?
TheraPsil prioritizes a human-centric environment where people of all backgrounds and ages can contribute and grow. To succeed, we must work together with a human-first approach because our people and team are our greatest strength, leading to our continued success in improving the lives of our stakeholders.
We offer:
- Training and career development opportunities internally.
- Strong emphasis on personal and professional growth.
- Friendly, supportive, remote working environment.
- Opportunity to work with colleagues based all over Canada with English as the company language (Bonus if you speak French!).
How to Apply
To ensure your application is considered, please email your resume and a 1-page cover letter to spencer@therapsil.ca and cc kamaya@therapsil.ca by May 12.