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Clinical Research Associate I

2 months ago

Canada Syneos Health Full time

About the Role

Syneos Health is seeking a highly skilled and experienced Clinical Research Associate I - Senior to join our team. As a Clinical Research Associate I - Senior, you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key Responsibilities

  • Site Qualification and Initiation
    • Perform site qualification and initiation visits to ensure the site is prepared to conduct the study.
    • Verify the site's understanding of the protocol, informed consent, and other study-related documents.
  • Interim Monitoring and Site Management
    • Perform interim monitoring visits to ensure the site is adhering to the protocol and regulatory requirements.
    • Manage site-level activities, including communication with site staff, to ensure project objectives, deliverables, and timelines are met.
  • Close-out Visits
    • Perform close-out visits to ensure the site has completed all study-related activities and has returned all study documents.
    • Verify the site's compliance with regulatory requirements and ensure all study-related documents are accurate and complete.
  • Documentation and Reporting
    • Document all site visits, including site qualification, initiation, interim monitoring, and close-out visits.
    • Prepare and submit reports to the project team, including site visit reports, query resolution reports, and other study-related documents.
  • Communication and Collaboration
    • Communicate effectively with site staff, project team members, and other stakeholders to ensure project objectives, deliverables, and timelines are met.
    • Collaborate with the project team to resolve issues and ensure the study is conducted in accordance with regulatory requirements and the protocol.

Requirements

  • Education
    • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Experience
    • Minimum 2 years of experience in clinical research, preferably in a CRA role.
  • Skills
    • Excellent communication, presentation, and interpersonal skills.
    • Basic level of critical thinking skills expected.
    • Ability to manage required travel of up to 75% on a regular basis.

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.