Senior CF CRA Consultant (San Jose, CA)

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.
 

• 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.
   

• 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 Clients
This is a full time position