Clinical Research Associate

3 days ago

Hamilton, Canada Platform Life Sciences Inc. Full time

**About Us**:
Platform Life Sciences was founded in February of 2021 in response to an unmet need for disruptive global clinical research rapidly and effectively generating clinical evidence for COVID-19. We designed and implemented the TOGETHER Trial which received global recognition. The TOGETHER Trial was a pathfinder of new platform/adaptive trial methodology and execution at global scale, and Platform Life Sciences is the organization dedicated to making this happen. We are headquartered in Vancouver, BC with satellite offices in the USA, Brazil, Pakistan, Rwanda, and South Africa. Our founders and scientific leaders are serial entrepreneurs and professors at established universities

**Role Summary**:
**Reporting to the Clinical Trials Manager, your key responsibilities will be to**:

- Developing clinical trial protocols and related documentations, including case report forms, management plans, study-specific procedures, and reference/training materials.
- Liaising with participating clinical sites and overseeing trial activities at participating sites.
- Liaising with contract research organizations, contracted vendors, and external collaborators to facilitate daily trial activities.
- Coordinating the collection, delivery, entry, verification, and management of clinical trial data.
- Participating in clinical site monitoring activities.
- Developing and maintaining electronic trial master files.
- Leveraging clinical trial management software systems to track trial milestones, deliverables, and quality metrics.
- Ensure that all trial activities are conducted in accordance with the trial protocol, ICH-GCP guidelines and all applicable regulatory requirements.
- Drafting sections of clinical trial reports and manuscripts.
- Organizing and participating in team meetings and teleconferences.

**Education**:

- Basic requirement is a bachelor’s degree in a health-related discipline.
- **Preferred educational requirement is a post-graduate degree in a health-related discipline**.

**Experience**:

- At least 5 years of relevant research experience, ideally including experience working on FDA or Health Canada-regulated clinical trials.
- Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical research methodology.
- Ability to function both independently and in a team environment.
- Effective time management skills and the ability manage multiple competing priorities.
- Demonstrated ability in writing clinical research related documents.
- Superior communication skills and strong ability to plan and organize.
- Strong attention to details and ability to utilize critical thinking for problem solving.
- Strong teamwork capabilities with flexibility to thrive in dynamic environments.

**Company**: Platform Life Sciences, 1505 West 2nd Ave., Vancouver, British Columbia

**Employment**:Full-time

**Salary**:Commensurate with experience

**Location**: Hamilton, ON

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- relevant research: 5 years (preferred)

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