Clinical Trial Assistant

**JOB TITLE**:Clinical Trial Assistant, SBI ALApharma Canada Inc.

**REPORTING**:Reports to the Manager of Clinical Development, SBI ALApharma Canada Inc.

**GENERAL SUMMARY**

The incumbent will embrace SBI Canada’s core values:

- Foster and promote a healthy and respectful workplace environment.
- Value teamwork and an ‘all hands on deck’ mentality as we solve challenges.
- Build value for customers and investors.
- Innovation without ego.
- Relentlessly seek continuous improvement opportunities.
- Achieve results with a sense of urgency.
- Find how we can, not why we can’t.
- We value a profitable growing company; growth creates opportunities, profit allows pursuit of opportunities.
- We are intolerant of bureaucracy that adds no value to our customers.

**JOB **SUMMARY**

The Clinical Trial Assistant will support the implementation of clinical projects at SBI ALApharma Canada. The Clinical Trial Assistant will support the clinical operations team in operationalizing and executing clinical trials efficiently. Option for hybrid in-office and remote work available.

**DUTIES AND RESPONSIBILITIES**:

- Support clinical team to ensure projects meet the projected timelines
- Interact with personnel from investigational sites, vendors, and SBI ALApharma Canada to enable timely and high-quality initiation and completion of clinical trials
- Assist with the identification of sites for participation in clinical trials
- Act as the primary point of contact during site feasibility assessment phase of study start-up
- Compile and maintain accurate records of all sites and investigators engaged during site feasibility assessment phase
- Maintain and disseminate basic study tracking information including, but not limited to: visit reports, regulatory documents, site contact lists, team contact lists and vendor lists
- Coordinate, schedule and maintain records of meetings, such as sponsor-site team meetings, site evaluation visit, site initiation visits, training sessions, investigator meetings, off-site client or internal departmental meetings.
- Assist with preparation and submission of regulatory documents to responsible authorities and IRB/ECs.
- Assist with maintenance of Trial Master File
- Facilitate the execution of contracts
- Contribute to the development of documents that facilitate or describe the management of the clinical trial. Examples of such documents include, meeting presentations, study guides or manuals, and information collection tools.
- Oversight of preparation, shipment and management of study supplies to sites
- Maintain study portals, web sites, or newsletters.
- Assist with processing vendor invoices and expense reports.
- Support sites in their efforts to prepare for audits conducted either by sponsors or regulatory authorities.
- Compile documentation for qualification of clinical sites, as required. Support review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations.

**COMPETENCIES**:

- Excellent interpersonal and problem-solving skills.
- Detail oriented and organized.
- Experienced in coordinating workloads to meet deadlines.
- Decisive, good decision-making skills, able to escalate response to situations when relevant.
- Independent worker, self-directed and able to work with mínimal supervision.
- Results oriented with personal responsibility for delivering on commitments.
- Ability to interact effectively and professionally with team, stakeholders, vendors, and service providers.
- Knowledge of Clinical Trial process and demonstrated ability to analyze and understand the clinical trial protocols.
- Principles of clinical trial conduct; understanding of Good Clinical Practices (GCP)
- Ability to work as a team.

**QUALIFICATIONS**:

- Post-secondary degree in a science or healthcare related discipline preferred.
- 2+ years work experience as a clinical trial assistant required.
- Knowledge of ICH-GCP.
- Knowledge of Trial Master File requirements desired.