Clinical Trials Associate (CTA)

About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

• The Clinicals Trial Associate will provide support to the Clinical Operations team in the planning, execution, and management of clinical trials and programs. They will work collaboratively with the Clinical Project Manager (CPM), Clinical Trials Manager (CTM), Clinical Research Organization (CRO) representative(s), vendors, and other CG Oncology functional departments (as required).

Location: Remote

Essential Functions

• Assist with review of Site Contracts, Site Budgets, and Site CDA's.
• Evaluate and approve regulatory documents required for Local/Central IRB Submissions, EC Submissions, through investigational product greenlight/ release.
• Assist in providing oversight & accountability to third party vendors assigned to a study or program.
• Maintain study electronic Trial Master File (eTMF).
• Maintain Electronic Data Capture system (EDC).
• Manage and update study trackers for patient enrollment, site monitoring visits, patient visit schedules, protocol deviations.
• Conduct remote review on study data and identify data trends on a continuous basis.
• Assist with investigator site management process: site start-up, regulatory documents collection and review, and investigational product and supplies shipments.
• Participate in site visits (initiation, interim monitoring, and closeout) as needed.
• Perform all clinical department administrative tasks as assigned and recommend process improvements

Qualifications

• Bachelor's Degree in Biological Sciences or Nursing or other relevant discipline
• Five (5) years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO.
• Previous experience in creating, managing, and auditing clinical trial master files.
• Ability to travel overnight on a short notice up to 20%

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page …