Senior CF CRA Consultant (San Jose, CA)

Company: Cedent Consulting Inc
Location: San Jose
Posted on: November 8, 2024

Job Description:

We are seeking an experienced Senior Clinical Research Associate Consultant to support the clinical operations strategy for a CF program. As a proactive team player with strong expertise in clinical operations, you will work closely with Clinical Operations and cross-functional teams to drive the next wave of genetic medicines. This role requires substantial experience in rare diseases or genetic medicines, such as mRNA, gene therapy, or gene editing.Key Responsibilities:

• Support the Clinical Operations Study team in ensuring timely and efficient trial initiation and completion.
• Assist with CRO activities, including site feasibility, qualification, initiation, and interim monitoring.
• Develop or assist in the creation of trial materials and activities for identifying rare disease patients.
• Collaborate with the Clinical Operations Program Lead, providing training to CRO and site staff.
• Track, monitor, and present key study performance metrics to the cross-functional team.
• Manage delegated trial processes from the Clinical Operations Study team.
• Review data listings for accuracy, oversee data discrepancy management, and provide training/retraining to site staff and CRAs as needed.
• Coordinate with CRO and vendors on start-up activities, including ethics submissions.
• Escalate issues promptly to the Clinical Operations Program Lead and Head of Clinical Operations.
• Foster strong working relationships with the study team and clinical trial sites.
• Travel as needed for site initiation and co-monitoring visits.Qualifications:
  • BS/BA with 4+ years of Clinical Operations experience in biotech/pharma across Phase 1-3 trials.
  • Preferred experience in rare diseases or orphan drugs.
  • Knowledge of ICH GCP guidelines and clinical monitoring procedures.
  • Experience with clinical trial vendors, including CROs, imaging, home health, and patient recruitment.
  • Highly responsive and proactive team player with a growth mindset for problem-solving.
  • Strong organizational skills and the ability to manage multiple projects simultaneously.
  • Excellent communication and interpersonal skills, effective in cross-functional and fast-paced environments.
  • Creative problem-solving abilities, especially for rare disease programs.
  • Ability to champion change in a dynamic, growing environment.Department: Direct ClientsThis is a full-time position.
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Keywords: Cedent Consulting Inc, Lodi , Senior CF CRA Consultant (San Jose, CA), Professions , San Jose, California