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.
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