Clinical Trials Coordinator

**Clinical Trials Coordinator - Psychedelic-Assisted Group Psychotherapy (MDMA & Psilocybin)**
- **Remote (Ontario or Quebec Preferred) | Part-time Consulting (10-20 hours/week) | Potential for Full-time**

Are you passionate about **groundbreaking mental health research** and **psychedelic-assisted therapy**? Do you have deep expertise in **clinical trial coordination, Health Canada compliance, and Good Clinical Practice (GCP)?** If so, we’d love to meet you.

At **Field Trip Health**, we’re on a mission to revolutionize mental health care through evidence-based **psychedelic-assisted psychotherapy**. We’re currently conducting two pioneering **clinical trials**:

- **MDMA-Assisted Group Psychotherapy for Wellness**:

- **Psilocybin-Assisted Group Psychotherapy for Wellness**

To ensure these studies are **compliant, efficient, and generate high-quality data**, we’re seeking a **Clinical Trials Coordinator** to oversee their execution **from start to finish.**

You'll work closely with the **CEO, Director of Operations, and Director of Research & Clinical Trials**, ensuring these trials **run smoothly, adhere to Health Canada regulations, and contribute to groundbreaking psychedelic research.**

**What You’ll Be Doing**

**Regulatory & Compliance Oversight**
- Serve as the **primary point of contact with Health Canada** for all trial-related inquiries, submissions, and audits.
- Prepare, submit, and manage **Clinical Trial Applications (CTAs), protocol amendments, and regulatory reports.**:

- Ensure full compliance with **Health Canada’s Food and Drugs Act, the Controlled Drugs and Substances Act, and Good Clinical Practice (GCP) guidelines.**:

- Oversee the **proper storage, handling, and security of MDMA and psilocybin** in alignment with federal regulations.
- Conduct **internal audits** and **monitor trial sites** to proactively identify and resolve compliance risks.

**Clinical Site & Staff Training**
- Develop and oversee **training programs for therapists, nurses, physicians, and support staff** involved in the trials.
- Conduct **GCP, protocol, and ethics training** to ensure full regulatory adherence.
- Ensure trial teams follow strict **protocol compliance, informed consent procedures, and risk management strategies.**:

- Lead **trial start-up meetings, site initiation visits (SIVs), and ongoing trial site monitoring.**

**Participant Recruitment & Retention**
- Develop and execute **recruitment strategies** to meet participant enrollment goals.
- Oversee **participant screening, informed consent, and onboarding processes** to ensure eligibility and safety.
- Implement **retention strategies** to minimize dropout rates and maintain trial integrity.

**Data Collection, Monitoring & Final Analysis**
- Ensure all **electronic Case Report Forms (eCRFs) and data collection processes** meet GCP and regulatory standards.
- Work closely with statisticians and researchers to **coordinate data analysis and prepare final trial reports.**:

- Facilitate **Data and Safety Monitoring Board (DSMB) reviews** and ensure protocol adherence.

**Adverse Events & Risk Management**
- Establish **adverse event (AE) and serious adverse event (SAE) reporting protocols** to Health Canada.
- Implement **risk mitigation strategies** to ensure participant safety and regulatory compliance.

**Ethics & Institutional Review Board (IRB) Coordination**
- Manage **Research Ethics Board (REB)/IRB submissions** and ensure ongoing study approvals.
- Ensure compliance with **participant confidentiality, data security, and ethical research principles.**

**Budget, Contracts & Vendor Management**
- Oversee **trial budgets, financial planning, and vendor contracts** (e.g., pharmaceutical suppliers, data monitoring teams).
- Ensure proper procurement and **handling of psychedelic substances** per regulatory guidelines.

**Final Trial Analysis & Publications**
- Work with research teams to **analyze trial data, publish results, and present findings at scientific conferences.**:

- Ensure **final regulatory reporting and study closure** requirements are met.

**What You Bring**
- **Advanced degree in Clinical Research, Regulatory Affairs, Psychology, Neuroscience, or a related field** (PhD, MD, RN, or MSc preferred).
- **3+ years of experience in clinical trial coordination, ideally in psychedelic-assisted therapy or mental health research.**:

- **Deep expertise in Health Canada clinical trial regulations, ICH-GCP guidelines, and controlled substances protocols.**:

- Strong understanding of **psychotherapy models, psychedelic-assisted therapy frameworks, and research methodologies.**:

- Experience with **adverse event reporting, participant safety monitoring, and compliance audits.**:

- **Proven ability to lead cross-functional teams** and work collaboratively across departments.
- Excellent communication skills for engaging with **Health Canada, ethics boards, and key stakeholders.**

**Why Join Field Trip Health?**
- **Pioneering R