Job description

Why Work for us?

At Virogin Biotech, every day we strive to achieve incredible progress by working together to pursue our shared mission in developing novel oncolytic immunotherapies/mRNA vaccines and improving the lives of our patients. With our vision to be a global, best-in-class oncolytic virus company and with our patients’ welfare always at the top of our priorities, our teams work together to create impactful drugs for cancer patients with the hope of solving one of the world’s biggest challenges - a future without cancer.

Position Overview

With this opportunity, you’ll join a team of diverse and dedicated problem solvers, continuously challenging each other to bring forward diverse perspectives and insights that ignite innovation and make a difference to the work that we do. We are seeking a highly motivated professional who is looking to grow their career with our company.

As a Senior Clinical Research Associate, you will be part of a growing team and be responsible for all aspects of clinical trial site visits, monitoring and management in North America (USA & Canada). The successful candidate will maintain appropriate documentation regarding site management, monitoring visit findings and creating actions plans where required.

Responsibilities and work you’ll be part of

• Conduct Pre-Selection Visit (PSV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), and Close-Out Visit (COV) at assigned sites in accordance with contracted scope of work and Good Clinical Practice (GCP)
• Create and maintain appropriate documentation regarding site management, monitoring visit findings, and create action plans by generating regular visit reports, follow-up letters and other required study documentation
• Support the development of study subject recruitment plan for each clinical site, and work with sites to adapt, drive and track the plan in line with project needs
• Monitor the completeness and quality of regulatory documentation, and perform site document verification
• Establish regular lines of communication with sites to manage ongoing project expectations and issues
• Review the Electronic Data Capture (EDC) platform for completeness and accuracy, and conduct data query generation and resolution
• Manage the progress of assigned studies by tracking regulatory submissions, approvals, recruitment, and enrollment
• Escalate quality issues as appropriate
• Collaborate and liaise with study team members for project execution support as appropriate
• Perform central monitoring
• Other duties as required

Experience and Skills you’ll bring to the role

• Bachelor’s Degree in Life Sciences or equivalent experience with a Nursing background
• Minimum of 2-3 years of independent on-site clinical monitoring experience
• Oncology experience and working on phase 1 trials strongly preferred
• Thorough and in-depth Good Clinical Practice (GCP) knowledge
• Advanced site monitoring and management skills
• Strong attention to detail, organization, and problem-solving abilities
• Valid Driver's License

The following experiences or abilities are assets

• Previous experience as an Oncology nurse is an asset

Working conditions

• Works remotely and will need to work flexible work hours
• Works with minimal supervision
• Travel, including air travel, is required and is an essential function of the job
• 50 - 70% business travel required

Join Virogin Biotech’s team of creative and motivated professionals in making a difference to solve the world’s biggest challenges—a future without cancer. For more information about our company, visit www.virogin.com

Job Type: Full-time

Salary: From $100,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
COVID-19 vaccination is an employment requirement; accommodations will be considered upon request.

Education:

• Bachelor's (Required)

Experience:

• Onsite clinical monitoring: 1 year (Preferred)
• Oncology: 1 year (Preferred)

Willingness to travel:

• 50% (Preferred)

Work Location: Remote

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